8100E SRV English

nGenuityTM
8100E Series
Vital Signs Monitor
Service Manual
Cat. No. 1448 Part No. 39166B101

Date 12/07 Revision 1
Copyright
COPYRIGHT © CRITICARE SYSTEMS, INC. 2007
CRITICARE SYSTEMS, INC., (Criticare) owns all rights to this unpublished work
and intends to maintain this work as confidential. Criticare may also seek to
maintain this work as an unpublished copyright. This publication is to be used solely for
the purposes of reference, operation, maintenance, or repair of Criticare equipment.
No part of this publication may be reproduced in any manner or disseminated for
other purposes.
In the event of inadvertent or deliberate publication, Criticare intends to enforce its

rights to this work under copyright laws as a published work. Those having access
to this work may not copy, use, or disclose the information in this work unless
expressly authorized by Criticare to do so.
All product specifications, as well as information contained in this publication, are

subject to change without notice.
All information contained in this publication is believed to be correct. Criticare

Systems, Inc., shall not be liable for errors contained herein nor for incidental or
consequential damages in connection with the furnishing, performance, or use of
this material.
This publication may refer to information and products protected by copyrights or

patents and does not convey any license under the patent rights of Criticare
Systems, Inc., nor the rights of others. Criticare Systems, Inc., does not assume
any liability arising out of any infringements of patents or other rights of third
parties.
PROPERTY OF CRITICARE SYSTEMS, INC.

ALL RIGHTS RESERVED
nGenuity™ vital signs monitor, DOX™ Digital Oximetry, ComfortCuff™ NIBP,

SHELL™ and Multi-Site™ SpO2 Sensors are trademarks of Criticare Systems, Inc.
Page ii nGenuityTM 8100E Series Service Manual Criticare Systems, Inc.

Contents
Copyright................................................................................................................ii
Contents................................................................................................................ iii
Warranty............................................................................................................... vii
Service Return Policy.......................................................................................... viii
EC Declaration of Conformity................................................................................ix
Section 1 - Introduction
Description .................................................................................................................... 1-1

Intended Use................................................................................................................. 1-1
nGenuity 8100E Series Options.................................................................................... 1-1
Pulse Oximetry Measurement (SpO2) .......................................................................... 1-2
Definition ............................................................................................................ 1-2
DOX™ Digital Oximetry ..................................................................................... 1-2
Method ............................................................................................................... 1-2
SpO2 Clinical Testing and Accuracy .................................................................. 1-3
Heart Rate..................................................................................................................... 1-4
ECG Measurement ....................................................................................................... 1-4
Method ............................................................................................................... 1-4
Stability of Accuracy........................................................................................... 1-5
Pacemaker Pulse Rejection ............................................................................... 1-5
Respiration.................................................................................................................... 1-5
Non-Invasive Blood Pressure (NIBP)............................................................................ 1-6
Comfort Cuff™ Technology................................................................................ 1-6
Description of NIBP Measurement..................................................................... 1-6
NIBP Clinical Testing and Accuracy................................................................... 1-7
Cuff Inflation and Pressure Protection ............................................................... 1-7
Capnography (Measurement of CO2) ........................................................................... 1-8
Method of Measurement .................................................................................... 1-8
Conditions of Use............................................................................................... 1-9
Stability of Accuracy........................................................................................... 1-9
N2O Compensation ............................................................................................ 1-9
Temperature Measurement .......................................................................................... 1-9
Specifications.............................................................................................................. 1-10
Symbols ...................................................................................................................... 1-14
Safety.......................................................................................................................... 1-16
Definitions ........................................................................................................ 1-16
Warnings .......................................................................................................... 1-16
Cautions ........................................................................................................... 1-17
Leakage Current .............................................................................................. 1-18
Voltage Fluctuations......................................................................................... 1-18
Equipotential Ground ....................................................................................... 1-18
Software Error Related Hazard Mediation ....................................................... 1-18
Potential Interference ....................................................................................... 1-19
Biocompatibility ................................................................................................ 1-19
Latex Content................................................................................................... 1-19
DEHP Content.................................................................................................. 1-19
Section 2 - Service Windows
Service Mode Window .................................................................................................. 2-1

Service Mode Window ....................................................................................... 2-1
NIBP Service Mode............................................................................................ 2-4
Processor Software Download........................................................................... 2-5
Permanent Alarm Silence .................................................................................. 2-6
Arrhythmia and ST Analysis............................................................................... 2-6
Criticare Systems, Inc. nGenuityTM 8100E Series Service Manual Page iii
Service Settings ............................................................................................................2-7
Service Password...............................................................................................2-7
Alarm Tone Warning...........................................................................................2-8
Line Frequency...................................................................................................2-8
Simulation Mode.................................................................................................2-9
Custom Profiles ...........................................................................................................2-10
Setting Patient Size ..........................................................................................2-10
Creating Custom Profiles..................................................................................2-11
Section 3 - Theory of Operation
Power Module ...............................................................................................................3-1

Main CPU and System ..................................................................................................3-1
CONM Module....................................................................................................3-1
Vital Signs Module..............................................................................................3-1
Speaker Driver....................................................................................................3-1
ECG Module..................................................................................................................3-2
Impedance Respiration.......................................................................................3-2
Pulse Oximeter Module (SpO2).....................................................................................3-3
Temperature..................................................................................................................3-3
Communications............................................................................................................3-3
Printer............................................................................................................................3-3
Block Diagram ...............................................................................................................3-4
Section 4 - Cleaning and Disinfecting
Cleaning and Disinfecting..............................................................................................4-1

Pulse Oximeter Sensors.....................................................................................4-1
Blood Pressure Cuffs..........................................................................................4-1
ECG Cable .........................................................................................................4-2
Temperature Cable.............................................................................................4-3
Accidental Wetting.........................................................................................................4-4
Section 5 - Preventative Maintenance
Incoming Inspection ......................................................................................................5-1

Maintenance Schedule..................................................................................................5-1
Monitor Safety Testing ..................................................................................................5-2
Equipment and Tools..........................................................................................5-3
Accessory Testing ..............................................................................................5-3
Fuse Removal/Replacement .........................................................................................5-4
Long-Term Monitor and Battery Storage.......................................................................5-5
Monitor and Accessories Disposal ................................................................................5-5
Electrical Safety Testing................................................................................................5-6
Equipment Needed.............................................................................................5-6
Withstanding Voltage (Hi-Pot) Test Equipment and Setup.................................5-6
Withstanding Voltage (Hi-Pot) Test Procedure...................................................5-7
Leakage Test Equipment and Setup ..................................................................5-8
Leakage Test Procedure ....................................................................................5-8
Ground Continuity Test.....................................................................................5-10
Functional Testing .......................................................................................................5-11
Interface Inspection ..........................................................................................5-11
Manual Controls Check ....................................................................................5-11
Alarms Verification............................................................................................5-12
Printer Check....................................................................................................5-12
Page iv nGenuity™ 8100E Series Service Manual Criticare Systems, Inc.

Module Verification ..................................................................................................... 5-13
ECG Verification............................................................................................... 5-13
ECG Analog Output Test ................................................................................. 5-16
Diagnostic, Monitor, and ST Filter Mode Tests ................................................ 5-17
SpO2 Verification ............................................................................................. 5-18
NIBP Verification .............................................................................................. 5-19
Temperature Verification.................................................................................. 5-20
Communication Testing .............................................................................................. 5-21
Nurse Call ........................................................................................................ 5-21
Battery and Power Testing.......................................................................................... 5-22
Test the Battery................................................................................................ 5-22
Functional and Safety Testing Checklist..................................................................... 5-23
Section 6 - Service Testing and Calibration
Field Service Testing Safety ......................................................................................... 6-1

Field Service Test Matrix .............................................................................................. 6-2
Field Calibration Procedures......................................................................................... 6-2
DOX SpO2 Performance Testing .................................................................................. 6-3
Programming the SmartSat Analyzer................................................................. 6-3
Test Procedure................................................................................................... 6-3
SpO2 Board Test Values.................................................................................... 6-4
NIBP Calibration ........................................................................................................... 6-5
Installing the PC Service Program ..................................................................... 6-5
Configuring the Ports ......................................................................................... 6-5
Calibration .......................................................................................................... 6-6
NIBP Performance ............................................................................................. 6-9
Temperature Input Check ........................................................................................... 6-10
Monitor Fault Testing .................................................................................................. 6-11
Power Supply Board Test ................................................................................ 6-11
Main Board Testing..................................................................................................... 6-12
Section 7 - Disassembly
Before You Begin.......................................................................................................... 7-1

Tools Needed..................................................................................................... 7-1
Before You Begin ............................................................................................... 7-1
Service Safety .................................................................................................... 7-1
Electrostatic Discharge Protection ..................................................................... 7-2
Disconnecting and Replacing the Battery ..................................................................... 7-2
Remove the Battery ........................................................................................... 7-2
Reconnect or Replace the Battery ..................................................................... 7-2
Printer Repair................................................................................................................ 7-3
Removing Printer Assembly............................................................................... 7-3
Replacing Printer Components .......................................................................... 7-3
Reattach the Printer Assembly........................................................................... 7-3
Front Main Chassis Repair ........................................................................................... 7-4
Disassembly....................................................................................................... 7-4
PCB Replacement.............................................................................................. 7-4
Display Assembly.......................................................................................................... 7-6
Disassembly....................................................................................................... 7-6
Membrane Replacement.................................................................................... 7-6
Display Installation ............................................................................................. 7-6
Bottom Chassis Repair ................................................................................................. 7-7
Disassembly....................................................................................................... 7-7
Speaker Replacement........................................................................................ 7-7
NIBP Chassis Replacement............................................................................... 7-7
Power Supply Replacement............................................................................... 7-7
Testing .......................................................................................................................... 7-8
Assembly Tests............................................................................................................. 7-9
Criticare Systems, Inc. nGenuityTM 8100E Series Service Manual Page v

Section 8 - Troubleshooting
Troubleshooting and Repair ..........................................................................................8-3

ComfortCuff NIBP Module.............................................................................................8-3
ECG/Impedance Respiration Module............................................................................8-4
Board Settings and Module Software .................................................................8-4
Respiration .........................................................................................................8-4
Temperature .......................................................................................................8-4
DOX SpO2 Module ........................................................................................................8-5
Main Board ....................................................................................................................8-5
Power Module ...............................................................................................................8-6
Fuse Replacement .............................................................................................8-6
AC Power Components ......................................................................................8-6
Section 9 - Drawings and Schematics
List of Drawings.............................................................................................................9-1
Assembly BOMs and Drawings ..........................................................................9-1
PCB Drawings and Schematics..........................................................................9-1
Final Assembly ..............................................................................................................9-2
8100E (Without Printer) ......................................................................................9-2
8100EP (With Printer).........................................................................................9-2
8100E1 (With CO2).............................................................................................9-2
8100EP1 (With CO2 and Printer)........................................................................9-2
Main Monitor Assembly ......................................................................................9-3
Main Monitor with CO2 Assembly.......................................................................9-4
Chassis Assemblies ...........................................................................................9-5
Bottom Chassis Assembly..................................................................................9-5
Power Supply with Brackets ...............................................................................9-6
Main Chassis Assembly .....................................................................................9-6
NIBP Chassis Assembly.....................................................................................9-7
CO2 Internal Module Assembly ..........................................................................9-8
CO2 External Module Assembly .........................................................................9-8
Display Chassis Assembly .................................................................................9-9
Assembly Patient Connectors ............................................................................9-9
Shielded Analog Board Assembly ....................................................................9-10
Printer ...............................................................................................................9-10
Appendix A - CO2 Service
Service Windows.......................................................................................................... A-1

Theory of Operations.................................................................................................... A-2
Capnometer Module (CO2)................................................................................ A-2
Block Diagram ................................................................................................... A-3
Preventative Maintenance............................................................................................ A-4
Maintenance Schedule ...................................................................................... A-4
CO2 Absorber Verification ................................................................................. A-4
Gas Flow/CO2 Verification................................................................................. A-5
Testing Checklist ............................................................................................... A-6
CO2 Calibration ............................................................................................................ A-7
Tools Needed .................................................................................................... A-7
Before You Begin .............................................................................................. A-7
Procedure .......................................................................................................... A-8
Disassembly ............................................................................................................... A-10
Disconnect the Battery .................................................................................... A-10
Check/Replace the CO2 Absorber................................................................... A-11
Replace the External CO2 Module .................................................................. A-12
Replace the Internal CO2 Module.................................................................... A-12
Troubleshooting.......................................................................................................... A-13
Verification Checklist .................................................................................................. A-14
Page vi nGenuity™ 8100E Series Service Manual Criticare Systems, Inc.

Warranty
Workmanship & Criticare Systems, Inc., (CSI) warranties new equipment to be free
Materials from defects in workmanship and materials for a period of one (1)
year from date of shipment under normal use and service. The 940
Series Multi-SiteTM Sensor carries a six month warranty. CSI’s
obligation under this warranty is limited to repairing or replacing, at
CSI’s option, any part which upon CSI’s examination proves
defective.
EXCEPT AS DESCRIBED IN THE PARAGRAPH ABOVE, CSI
MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
Exemptions CSI’s obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or
consequential damages or delay resulting from the improper use or
application of the product or the substitution upon it of parts or
accessories not approved by CSI or repair by anyone other than a
CSI authorized representative.
This warranty shall not extend to any instrument which has been
subjected to misuse, negligence or accident; any instrument from
which CSI’s original serial number tag or product identification
markings have been altered or removed; or any product of any other
manufacturer.
Safety, Reliability & Criticare Systems, Inc., is not responsible for the effects on safety,
Performance reliability and performance of the 8100E Series Patient Monitor if:
assembly operations, extensions, readjustments, modifications or
repairs are carried out by persons other than those authorized by
Criticare Systems, Inc., or
the 8100E Series Patient Monitor is not used in accordance with the
instructions for use, or
the electrical installation of the relevant room does not comply with
NFPA 70: National Electric Code or NFPA 99: Standard for Health
Care Facilities (Outside the United States, the relevant room must
comply with all electrical installation regulations mandated by the
local and regional bodies of government).
In Case of Emergency CRITICARE SYSTEMS, INC. Telephone: (262) 798-8282

Contact 20925 Crossroads Circle Tech Support: (800) 458-2697
Waukesha, WI 53186 Orders: (800) 458-4615
USA Fax: (262) 798-8290
Internet: www.csiusa.com
Criticare Systems, Inc. nGenuityTM 8100E Series Service Manual Page vii
Service Return Policy
Return Procedure In the event that it becomes necessary to return a unit to Criticare
Systems, Inc., the following procedure should be followed:
Obtain return authorization. Contact the CSI Service Department
at 800-458-2697 to obtain a Customer Service Authorization (CSA)
number. (Outside the US, call 001-262-798-8282.) The CSA number
must appear on the outside of the shipping container. Return
shipments will not be accepted if the CSA number is not clearly
visible. Please provide the model number, serial number, and a brief
description of the reason for return.
Freight policy. The customer is responsible for freight charges when
equipment is shipped to CSI for service (this includes customs
charges).
Loaner service. In the U.S. If it is necessary to provide a loaner
system, CSI will ship a loaner by overnight courier. The loaner system
must be returned to CSI at the customer’s expense within one week
after receipt of the repaired goods. If the unit is not returned to CSI
within that time, the customer will be invoiced for the full purchase
price of the equipment.
Outside the U.S. No loaners are available from CSI internationally.
Contact your local CSI representative.
Page viii nGenuityTM 8100E Series Service Manual Criticare Systems, Inc.
EC Declaration of Conformity
nGenuity 8100E Series To view the Declaration of Conformity, visit the Criticare website at
www.csiusa.com. A copy of the Declaration can also be faxed.
Patient Monitor Contact Criticare’s customer service department at (262) 798-8282 to
obtain a faxed copy of the Declaration.
Representative in the Criticare Systems Limited

European Union c/o Wright Hassall
9 Clarendon Place
Leamington Spa
Warwickshire
CV 32 5QP – United Kingdom
T: 0044 (0) 1926 886688
F: 0044 (0) 1926 885588
For the Attention of: Ref. 45 (or) Mr L. A. Heizler
Criticare Systems, Inc. nGenuityTM 8100E Series Service Manual Page ix

Section 1 — Introduction
Description The nGenuity 8100E Series monitor interprets and displays real time
physiological data including waveforms and numerical data. The
monitor is designed for multi-parameter measurements, including
ECG, NIBP, SpO2, temperature, and respiration. Optional CO2
monitoring is also available. For all these vital parameters, the 8100E
Series monitor has limit alarms and alerts. The monitor also prints
strip chart recordings and stores tabular trends for review.
Intended Use The 8100E Series monitor is intended to monitor physiological

parameters of patients within clinical care settings. It is intended that
the user is a professional health care provider. Physiological data,
system alarms, and patient data analysis are available to the care
provider from the monitor.
The user is responsible for the interpretation of the monitored data

that is made available. Physiological data should be reviewed by a
qualified clinical personnel prior to any medical intervention.
The monitor is designed to be used with only one patient at a time.

The monitor (including accessories) is capable of monitoring a full
range of patients from neonate to adult.
nGenuity 8100E Series The nGenuity 8100E Series monitor comes standard with 5-Lead
Options ECG, ComfortCuff™ NIBP, DOX™ SpO2, and one temperature
channel for monitoring. Options include internal printer and CO2
monitoring. A color TFT screen with a six waveform display is
standard on all nGenuity 8100E Series models.
The nGenuity 8100E Series monitor is also available with ST and

Arrhythmia analysis as an option.
Catalog Number Printer Additional Features
8100E No Standard
8100E-ST No ST Arrhythmia
8100E1 No CO2
8100E1-ST No CO2, ST Arrhythmia
8100EP Yes Standard
8100EP-ST Yes ST Arrhythmia
8100EP1 Yes CO2
8100EP1-ST Yes CO2, Arrhythmia
Criticare Systems, Inc. nGenuity™ 8100E Series Service Manual Page 1-1
Pulse Oximetry The monitor uses Digital Oximetry (DOX) technology to measure
Measurement (SpO2) blood oxygen saturation (SpO2).
Definition Hemoglobin exists in the blood in several forms:

• Oxygenated (Oxyhemoglobin)
• Reduced (Deoxyhemoglobin)
• Dyshemoglobins (carboxyhemoglobin and methemoglobin.)
In the monitor, SpO2 (pulse arterial oxygen saturation) is the ratio of

oxygenated hemoglobin to the sum of oxygenated hemoglobin plus
hemoglobin which is available for binding to oxygen, as expressed in
the following formula:
oxyhem oglobin
per ce nt oxygen sa tura tion = ------------------------------------------------------------------------------------------------ × 100
oxyhem oglobin + de oxyhem oglobin
Dyshemoglobins, such as carboxyhemoglobin and methemoglobin,

are not directly measured and therefore are not factored into the
measurement.
DOX™ Digital Oximetry The monitor does not use analog circuitry for signal processing.
Digital signal processing in the microprocessor results in lower noise
from circuitry components, resulting in a cleaner signal and better
performance under low perfusion conditions. There is also improved
rejection of noise from the patient and environment, due to the
availability of the “true,” unfiltered sensor signal for digital signal
processing.
Method The digital pulse oximeter measures oxygen saturation and pulse rate
using the principles of spectrophotometry and plethysmography. The
sensor is completely non-invasive, and there is no heat source that
could burn the patient.
The pulse oximeter sensor contains two types of LEDs. Each type
emits a specific wavelength of light. Since oxygenated hemoglobin
and deoxygenated hemoglobin absorb light selectively and
predictably, the amounts of these two compounds can be determined
by measuring the intensity of each wavelength that passes through
the measuring site.
Page 1-2 nGenuity™ 8100E Series Service Manual Criticare Systems, Inc.
The light from the LEDs shines into a pulsating vascular bed. A
photodetector located opposite or alongside the LEDs measures the
intensity of each wavelength transmitted through the monitoring site.
The light intensity is converted to an electrical signal, which is input to
the monitor. The effects of skin pigmentation, venous blood, and
other tissue constituents are eliminated by separating out the
pulsating absorption data.
SpO2 is calculated with every pulse and averaged with the results
from previous pulses to arrive at the current numeric display value.
The display is updated at least once per second with the numeric
values that were calculated during the intervening period.
The plethysmographic pulse wave is not auto-gained. The amplitude

display of the plethysmographic pulse wave is proportional to the
pulse volume changes occurring in the tissue illuminated by the SpO2
sensor.
SpO2 Clinical Testing All Criticare oximeters (DOX™ compatible) have SpO2 calibration
and Accuracy tables which were originally generated by monitoring desaturated
human patients or volunteers and matching their displayed SpO2
value to the value determined by sampling arterial blood and
measuring functional SaO2 with a clinical laboratory grade multi
wavelength optical oximeter (i.e. CO-oximeter). The final SpO2
calibration curve was then generated based upon numerous patients'
data over the range of 40 to 99% SaO2. All accepted data were taken
from patients with dyshemoglobin (i.e., carboxyhemoglobin,
methemoglobin) concentrations near zero.
This oximeter is a two-wavelength device, which is calibrated to

measure functional SpO2 only when dyshemoglobin concentrations
are near zero. The accuracy specifications of this device will not be
met with high concentrations of dyshemoglobins. Significant
concentrations of carboxyhemoglobin results in a higher displayed
SpO2 value than is actually present in the patient.
SpO2 clinical accuracy validation to CO-oximeter SaO2 readings was

performed for this sensor using a DOX-compatible monitor.
The personal demographics of the study participants for the SpO2

clinical accuracy validation include a mix of adult males and females
from 18–45 years of age. All were healthy during the course of the
study. Physical characteristics and skin tone were by chance with a
mix from slight to stout and light to dark.
Heart Rate The heart rate is determined primarily from the ECG waveform data.
A beat detection algorithm is used to identify QRS beats.
The monitor has a user selectable smart heart rate function. It

automatically uses alternate sources to determine heart rate, if the
primary source becomes unmeasurable. The plethysmograph (SpO2
waveform) is used if the ECG heart rate is unavailable. In the
absence of SpO2 and ECG data, the NIBP oscillometric data is the
final default source for a heart rate measurement.
Response times for the ECG heart rate meter change from 80 BPM to
40 BPM and from 80 BPM to 120 BPM is less than or equal to 10
seconds. The alarm for tachycardia is less than or equal to 10
seconds per EC-13.
The pulse rate accuracy for SpO2 is the root-mean-square (rms)

difference between paired pulse rate data recorded with the pulse
oximeter and a reference method.
NOTE: The accuracy of the heart rate depends upon the source. The
range of the measurable NIBP based heart rate does not extend as
far as the range available in other modules used by the smart heart
rate feature.
NOTE: The NIBP based heart rate is not a continuous measurement

and is only current during an NIBP measurement.
ECG Measurement The electrocardiogram (ECG or EKG) records the changing potential
generated by electrical activity of the heart.
Method To obtain an overall view of the heart's electrical activity, three or five
electrodes attached to lead wires detect electrical impulses from the
patient's heart to the skin. The monitor calculates the difference in
electrical force between two electrode sites. Electrode polarity
(positive, negative, or ground) depends on the cable receptacle the
lead wire is attached to and the lead selected on the monitor screen.
The ECG design uses the standard (conventional bipolar limb leads)
leads I, II, III using 3-lead or 5-lead cable accessory. With the 5-Lead
cable accessory, leads aVR, aVL, aVF, and V lead may also be
viewed.
The monitor has user selectable automatic lead switching capability

when using the 5-lead settings. If a lead becomes detached or is
unmeasurable, the monitor can automatically display an alternate
lead view using the remaining leads.
Stability of Accuracy The monitor is equipped with pacemaker detection and user
selectable pacer rejection. There are no known safety hazards due to
the operation of a cardiac pacemaker or other electrical stimulators
when used with this vital signs monitor.
The accuracy of the monitor is not affected by arrhythmia or other

physiological conditions where the electrocardiogram amplitude and
heart rate are within the detectable limits specified for the monitor.
The monitor has user selectable signal filtering in the 60 Hz and
50 Hz bands that reduce electrical interference from the AC (mains)
power sources. User selectable filters are also available.
The accuracy of the ECG analog output bandwidth is equal to the

frequency response specified in the ECG specifications. The variable
gain control is x200, x400, or x800 (according to the ECG Sensitivity
setting). The propagation delay is 1000 milliseconds.
The accuracy of the synchronizing pulse amplitude is equal to 500

times that of leadview II. The pulse shape and duration match those
of leadview II. The output impedance is 1000 ohms and propagation
delay is less than 6.6 milliseconds.
Pacemaker Pulse Rejection With the pacemaker detector turned ON in the 8100E(P) Series, the
system detects and rejects pacemaker pulses ranging from ±2 to
±700 mV amplitude and 0.1 to 2.0 ms duration. Heart rates properly
display over this range of pacemaker operation. Pacer pulse markers
are present if pace detect is on and appear in the ECG analog output
as narrow positive spikes at the point of pace detection.
! CAUTION !
• Ambient noise sources may induce artifactual triggers of the
pacemaker pulse detector and display.
Respiration Respiration is measured via the ECG electrodes. The ECG uses the
impedance measurement based off of lead II.
When determining respiration from the ECG, the monitor measures

patient respiration by impedance pneumography. As the patient's
chest changes size and shape during inspiration and expiration, the
resistance between two chest (or abdomen) ECG electrodes
changes. Respiration rate is calculated from this change in
resistance.
The user may select ECG which uses the impedance measurement
based off the lead I or the CO2 respiration that is based off the
capnogram. There is also a selectable smart respiration function that
can automatically switch sources, if there is an interruption of
waveform data. The CO2 data is the primary source for the smart
respiration function and it defaults to the CO2 source if it is available.
Non-Invasive Blood The monitor uses ComfortCuff technology to determine non-invasive

Pressure (NIBP) blood pressure by means of oscillometry. The oscillometric method
detects volume displacements within the artery and senses pressure
variations within the blood pressure cuff during inflation. The monitor
uses cuffs ranging in size from neonate cuffs to thigh cuffs.
Comfort Cuff™ ComfortCuff technology measures NIBP while the cuff inflates.
Technology Consequently, a measurement is obtained more quickly and with less
discomfort than with monitors, which measure NIBP during cuff
deflation.
Description of NIBP The NIBP cuff begins to inflate at the beginning of the NIBP
Measurement measurement cycle. As the cuff pressure approaches the diastolic
pressure of the patient, the cuff pressure waveform begins to indicate
the pulse waveform. The cuff pressure at this point is equal to the
patient's diastolic pressure, which is stored by the monitor.
As cuff pressure continues to increase, the pulse waveform (as

measured from BP cuff pressure fluctuation) becomes stronger,
reaching its maximum at the patient's mean arterial pressure (i.e.,
when cuff pressure = mean BP). The monitor stores this value as
mean pressure.
As cuff pressure increases further, it approaches the patient's systolic
pressure, and the cuffs pulse waveform decreases in amplitude. The
cuff pulse waveform disappears at the point where cuff pressure is
equal to the patient's systolic pressure.
When the monitor determines that the cuff waveform has decreased
to zero amplitude, it stores the cuff pressure value as the systolic
pressure, and releases the pressure from the cuff. This typically
occurs at about 10 mmHg over the patient's systolic pressure. The
cuff then rapidly deflates.
Dynamic Measurement Ranges
Systolic (mmHg) Diastolic (mmHg) MAP (mmHg)
Adult 50-280 30-225 35-245
Pediatric 50-280 30-225 35-245
Neonate 50-135 20-100 30-120
NIBP Clinical Testing This device was clinically tested per the requirements of EN 1060 and
and Accuracy AAMI SP-10. The NIBP module as installed in the 8100E Series
monitor has been tested to meet the performance specifications
listed in this manual.
Cuff Inflation and The maximum cuff inflation rate is 15 mmHg/sec. The software limits
Pressure Protection inflation to 300 mmHg adult, 300 mmHg pediatric, or 150 neonate. A
secondary circuit limits maximum possible cuff pressure to 330
mmHg in adult/pediatric mode and 165 mmHg in neonatal mode. Cuff
pressure is allowed to remain above 30 mmHg for a maximum of two
minutes.
The monitor automatically deflates the cuff if the time limit is violated.
The monitor contains hardware protection for overpressure
conditions, pressure transducer failures, or microprocessor and pump
control circuit failures.
B.P Cuff Inflation Pressure
(Shown during inflation)
Systolic Pressure
Actual Blood
Pressure in mmHg
Pressure Waveform
Diastolic Pressure
Cuff deflates rapidly

after monitor determines
systolic pressure
Time
Pulse Waveform
(Measured from B.P. Cuff
Pressure Fluctuation)
Diastolic Mean Systolic

Pressure Pressure Pressure
Figure 1-1: NIBP Cuff Pressure and Pulse over Time
Capnography The 8100E Series monitor uses the sidestream method of measuring
(Measurement of CO2) CO2. Gas is aspirated through a nasal cannula or a ventilation circuit
adapter. The gas sample enters from a sampling tube into a water
trap, which removes water vapor and particulate matter from the gas
sample. The gas then enters the CO2 detector where it is analyzed.
The monitor measures CO2 concentrations and displays them in a

continuous waveform. The monitor also detects end-tidal and fraction
Inspired CO2 levels, displaying them numerically. End-tidal CO2
(ETCO2) is defined as the maximum CO2 concentration at the end of
expiration. The monitor measures and displays this numerical value
of CO2 concentration. The ETCO2 value is updated continuously with
each breath cycle. The amount of CO2 in the gas mixture inhaled in
by the patient is the fractional Inspired CO2 (FICO2).
Method of Measurement The monitor measures CO2 using the principles of infrared
absorption spectrometry. An unknown concentration of gas (CO2) is
calculated by comparing its absorption of infrared light to that of a
known standard. The absorption of light is directly related to the
concentration of gas. As infrared light passes through the sample
gas chamber, the light transmitted is converted to a voltage signal.
The monitor converts the voltage to CO2 concentration and
expresses it as mmHg, percent (%), kPa (user selectable), or Torr.
Infrared analysis of the gas samples is done using Beer’s Law.
The formula for Beer’s Law:
I = I0 e – ε (λ ) cd
I Infrared value of measured sample.
I0 Infrared value of light source.
e Exponential function.
ε( λ) Extinction coefficient.
c Concentration of the gas sample
d Distance measured through the sample
The Beer’s Law calculation is performed by the monitor’s software.
Conditions of Use The 8100E Series monitor has been calculated with dry NIST-
traceable calibration gases at room temperature and pressure
(~ 21C, 740mmHg). Given the small effect of water vapor upon the
CO2 measurement and the unit’s built-in temperature and pressure
measurements and compensations, this monitor’s method of gas
analysis is best described as ATPS (Ambient Temperature and
Pressure, Saturated; 21C 750mmHg, 100% Humidity Saturated).
The monitor is suitable for sustained pressure (breathing circuit)

monitoring environments and has been tested per clause 51.101
(Measurement Accuracy) of EN 21647: 2004.
Stability of Accuracy The monitor has an internal barometer and thermistor that allow
compensation for changes over a range of temperature and
atmospheric pressures. The monitor complies with EN 21647
standards for cyclical pressure and testing found negligible drift of
accuracy. The module as installed in the 8100E Series monitor has
been clinically tested for performance with a variety of patients.
N2O Compensation The monitor has a manual N2O compensation feature for a fixed N2O
value is 60%. The user may select N2O compensation when 40-80%
N2O is in use.
Temperature Body temperature is measured by the monitor using a thermistor

Measurement (temperature sensing elements in the temperature probe). The
thermistor can sense change in body temperature by changing
electrical resistance.
• Unusual, fast artificial variations in temperature readings may
occur with accompanying applications of an electrocautery
system.
• Electrical leakage current of the cable when used with the
monitor and sensor comply with IEC 601-1/EN 60601-1
The monitor is compatible with any YSI-400 or YSI-700 series

temperature probe.
Specifications ECG
Connectors: 3 or 5 Lead, Standard AAMI
Lead Selection: 3-Lead; I, II, III
5-Lead; I, II, III, aVR, aVL, aVF, V
Gain Selection: 0.5, 1.0, 2.0, 4.0
ECG Sensitivity Low 0.5, Medium 1.0, High 2.0, Auto
Frequency Response: Diagnostic; 0.05 - 100 Hz (-3db)
Monitor; 0.50 - 40 Hz (-3db)
Electrosurgery Protection: Yes
HF Equipment Protection: Yes
Defibrillator Protection: Yes
Pacer Detection/Rejection: Yes
Heart Rate
Source: Smart Switching;
ECG(primary), Pleth, NIBP
Range: 20-300 bpm (ECG, Pleth)
30-240 bpm (NIBP)
Accuracy: ± 1 bpm or 1% ECG, whichever is greater
(±3 bpm maximum)
Pulse Tone: Selectable, On/Off
Respiration
Source: ECG, CO2 (primary)
Rate Range: 6 to 150 breaths/minute (ECG)
0 to 120 breaths/minute (CO2)
Resolution: 1 breath/minute
Accuracy: ±1% or ±1 breath/minute, whichever is
greater
SpO2
Range: 1-99%
Resolution: 1%
Accuracy: 70-99% range; ± 2%;
50-69% range; ± 3%
<50%; unspecified;
Statistical, represents one st. dev. (~66%)
of clinical samples.
Indications Plethysmograph, Numerical, Audible
(pulse tone pitch varies with SpO2)
Method: Dual wavelength LED
Modes: Adult/Pediatric/Neonate
Operation: Continuous Use
Sensor Wavelength: 660nm/905nm
Sensor Power: <80mW
NIBP
Technique: Oscillometric measure upon inflation
Measurement Time: <40 seconds average; standard adult cuff
Automatic Measurement Cycles: 2, 3, 5, 10, 15, 30 min; 1, 2, 4 hrs
Inflation Pressure Range: Adult; 0 to 300 mmHg
Pediatric; 0 to 300 mmHg
Neonatal; 0 to 150 mmHg
Resolution: 1 mmHg
Transducer Accuracy: ± 2 mmHg or 2% of reading, whichever is
greater
STAT mode: 5 min of consecutive readings
Capnometry (CO2)
Units: mmHg; Percent; kPa; Torr
Display: Inspired CO2, Expired CO2 (End-Tidal)
Numerical values, capnogram, and
breath by breath ETCO2 bar graph.
Method: Non-dispersive Infrared, Auto-calibrating
Calibration: Auto-calibrating, Manual Calibration
Waveform Scale: Selectable, percent only
0 to 3.13, 6.25, 12.5 or 25%
Range: 0 to 99 mmHg, 0 to 12.5%
0 to 12.5 kPa, 0 to 99 Torr
Resolution: 1 mmHg, 0.1%, 0.1 kPa, 0.1 Torr
Accuracy: ±2 mmHg, ±0.3 vol%, ±0.3 kPa, ±2 Torr
@ 200 ml/min & RR <= 120 Br/min
N2O: Manual (On/Off)
Flow Rate: 200 ml/min
Flow Tolerance: 200 ml/min, ±10% (20 ml)
System Response Time: 1.25 seconds @ 200 ml/min
using an 8 ft sample line
Rise Time: 170 milliseconds @ 200 ml/min (10-90%)
Delay Time: 1.08 seconds
Time from cold start: 15 sec. (including auto-calibration) to first
reading; 1 min. to full accuracy
Pneumatic Sound Pressure: 35 dBa maximum @ 1 meter
Temperature
Channels: 1
Range: 68° - 113°F, 20° - 45°C
Accuracy: ± 0.1°C over entire range
Display Resolution: ± 0.1°C
Probe Type: YSI-400 or YSI-700
Alarms
Characteristics: EN 475, Adjustable
Indication: Audible; Visual
Levels: High, Medium, Low, Informational
Settings: User Defaults, Hospital Defaults,
Factory Defaults
Alarm Modes: Adult/Pediatric/Neonate,
High and low limit settings for each mode.
Volume: User Adjustable (1-10)
Silence: Yes; 2 minutes or permanent
Trend Reports
Types: Tabular and Graphical
Trend memory: 24 hours
Tabular Intervals: 30 sec., 1, 2, 5, 10, 15, 30 min., 1, 2, 4
hrs., NIBP (user selectable)
Graphical Span: 2, 4, 8, 12, or 24 hours
Data Types: BPM, HR, SpO2, Temp., Resp.,
NIBP (Systolic, Diastolic, Mean)
Printer (Optional)
Recorder Type: Internal thermal line printer
Data Formats: Single or dual waveform; Tabular
Paper Speed: 12.5 or 25mm/sec continuous.
(Snapshot at 50mm/sec)
Controls
Screen: 10.4" active color TFT
Resolution: 640 x 480 pixels
Waveforms: 6, maximum
Waveform Display Gain: 0.5×, 1×, 2×, 4× user selectable
Waveform Sweep Speed: 6.25, 12.5, 25 or 50 mm/sec, selectable
Keys: 9; membrane-activated
Rotary knob: Push and rotate; 24 steps/turn
Languages: English, French, German, Portuguese,
Spanish, Italian, Russian
System Outputs
Com Ports: RS 232-compatible; digital DB9 (COM 1);
mini-DIN8 (COM 2)
Nurse Call: Contact switch; audio jack 1/8 inch,
24V @ 100 ma maximum switching
Defibrillation Sync: BNC connector
Video Port: Serial VGA Compatible
Mechanical/Electrical
Weight: 14 lb; 6.4kg
Size: 11.0" (H) x 13.0" (W) x 10.3" (D)
28.0cm (H) x 33.1 cm (W) x 26.2cm (D)
Mechanical Shock: No affect when tested to IEC 60068-2-27
standards
Vibration: No affect when tested to IEC 60068-2-64
standards
Power Requirements: 35W, typical
Voltage: 100 - 240 VAC; 50/60 Hz
Number of Batteries: 1 sealed lead acid batteries
Battery Life: 3 hr, typical w/o CO2; 2.5 hr, typical w/CO2
Recharge time: 4.5 hours
Environmental
Operating Temperature: 59° - 95°F, 15° - 35°C
Storage Temperature: 23° - 122°F, -5° - 50°C
Operating and Storage Humidity: 15% to 90%; non-condensing
Medical Device: Class II Equipment (IIb EU)
Electrical Protection: Class I Equipment
Degree of Protection: Type CF, Defibrillator-Proof
Protection against ingress: IPX1
Altitude: -1,000 - 10,000 feet
All specifications are subject to change without notice.
Specifications related to the ST and Arrhythmia option are found in

the Arrhythmia and ST Analysis appendix in the 8100E operator’s
manual.
Symbols Symbol Definition
Refer to Operator’s Manual for Information
Shock Hazard
Equipotential Terminal
European Community Mark
Electrical Testing Laboratories (ETL) Mark
Do not dispose of in municipal waste. Wheeled bin

symbol indicates separate collection for electrical and
electronic equipment.
(WEEE Directive 2002/96/EEC)
Type CF Equipment, defib proof
Identifies the degree of protection against fluid as

IPX1 drip-proof.
Input/Output port
Output only port
Alarm port (Nurse call)
External display port
Symbol Definition
Fuse
Gas Scavenging
Air Intake
Alternating Current (AC)
Technical Support Phone Number
SN Serial Number
REF Part Reference Number
Placement of cuff over the brachial artery.

(Blood Pressure Cuff)
2 Single use device only. Do not reuse.
Recyclable cardboard/paper packaging.
Safety
Definitions Definitions for Warning and Caution symbols:

Designates a possible dangerous situation.
! WARNING ! Non-observance may lead to death or the most
severe injuries.
Designates a possible dangerous situation.

! CAUTION ! Non-observance may lead to minor injuries or
damage to the product.
Warnings
! WARNING !
• Read this manual entirely before attempting clinical use of the
monitor.
• Inspect For Damage! User should inspect the system for signs
of damage. Do not use the system if failure is evident or
suspected.
• Possible explosion hazard! Do not use the monitor in the
presence of gas mixtures which may be flammable.
• Do not use this device in conjunction with flammable
anesthetics such as cyclopropane and ether. The monitor can
sample from pure oxygen environments, but the monitor itself
should never be placed inside an oxygen rich environment, such
as an oxygen tent or gas containment apparatus. When not in
operation, this device is not intended to be connected to any
pressurized source containing an enriched oxygen environment.
• All cords must have hospital grade plugs and be plugged into
hospital grade outlets. (The electrical installation of the relevant
room must comply with NFPA 70: National Electric Code or
NFPA 99: Standard for Health Care Facilities. Outside the
United States, the relevant room must comply with all electrical
installation regulations mandated by the local and regional
bodies of government).
• Cables, cords, and leadwires may present a risk of
entanglement or strangulation! Verify safe and proper
positioning of these items after patient application.
• Leakage currents may increase if other equipment is
interconnected to the patient. The increased leakage currents
may present a hazard to the patient.
! WARNING !
• High Frequency (HF) surgical equipment may affect ECG
operation. The ECG waveform will return to normal momentarily
after the HF source is removed. Ensure that electrodes and
sensors are not placed near the HF source.
• Unapproved modifications to the monitor may cause unexpected
results and present a hazard to the patient. Unapproved use of
the accessories can also result present a hazard to the patient
or affect monitor performance.
• Do not re-use accessories labeled as single use. Risk of patient
contamination may occur.
• Improper disposal of batteries may result in explosion, leakage,
or personal injury. Do not open batteries. Do not dispose of
batteries in a fire. Follow all local regulations concerning the
disposal of spent Lead-acid batteries or contact Criticare for
assistance.
• Risk of electrical shock! Do not remove cover. Refer servicing to
qualified personnel.
• U.S. Federal law restricts this device to sale by or on the order
of a physician.
Cautions
! CAUTION !
• Use the monitor only with recommended accessories! Use of
unapproved accessories may cause inaccurate readings.
• Equipment accuracy may be affected at extreme temperatures.
• Do not store equipment at extreme temperature. Temperatures
exceeding specified storage temperatures could damage the
system.
• A possible explosion hazard exists! Do not use the monitor in
the presence of flammable anesthetics.
• Do not press on the keys with surgical instruments or other
tools. Sharp or hard objects could damage the keys. Use only
your fingertips to press on the keys.
• Do not allow the conductive parts of the patient electrodes to
contact other conductive parts, including ground (earth).
• Changes or modifications not expressly approved by Criticare
Systems, Inc., may void the user's authority to operate the
equipment and may also void the warranty.
• Always monitor patients with a pacemaker very closely, since
the 8100E may count at the pacemaker rate during cardiac
arrest or some arrhythmias.
Leakage Current The monitor complies with leakage current limits required by medical
safety standards for patient-connected devices. A hazard caused by
the summation of leakage currents is possible, when several pieces
of equipment are interconnected.
Connecting any external equipment to signal input, signal output, or

other connectors forms a system and this new system must comply
with the requirements of IEC 60601-1-1. If in doubt, contact qualified
technician or local representative.
Voltage Fluctuations When operated in the line voltage range specified in this manual any
fluctuation will have a negligible effect. Very low line voltage will
cause the monitor to revert to battery power. Very high line voltage
may cause damage to the charger circuits. The monitor is designed
with circuitry that turns the unit off before spurious readings can be
caused by a low battery condition.
Equipotential Ground Health care providers and patients are subject to dangerous,
uncontrollable compensating currents for electrical equipment. These
currents are due to the potential differences between connected
equipment and touchable conducting parts as found in medical
rooms.
The safety solution to the problem is accomplished with consistent

equipotential bonding. The monitor is fitted with a connecting lead
made up with angled sockets to the equipotential bonding network in
medical rooms.
Equipotential
Connection Lead
Terminal
(Socket)
Equipotential Main
Connector Body
Earth Ground
Software Error Related Criticare Systems, Inc., has quality control practices and procedures
Hazard Mediation in place to review potential hazards as they relate to software. The
monitor is Year 2000 Compliant and utilizes a 4 digit year for all date,
time, and leap year calculations.
Potential Interference This device has been successfully tested to IEC 601-1-2 specified
levels for emissions of and resistance to electromagnetic energy
fields. External disturbances which exceed these levels may cause
operational issues with this device. Other devices which are sensitive
to a lower level of emissions than those allowed by IEC 601-1-2 may
experience operational issues when used in proximity to this device.
MAGNETIC FIELDS
Use of the monitor in an MRI environment may interfere with MRI
image quality. Use of MRI may interfere with the monitor.
The 8100E Series patient monitor is not intended for use in MRI
environments.
RADIO FREQUENCY INTERFERENCE
The monitor conforms with IEC 1000-4-3 for radio frequency
interference, and will operate with negligible adverse effects.
CONDUCTED TRANSIENTS
The monitor conforms with IEC 61000-4-4, and IEC 61000-4-5 for
conducted transients, and will operate with negligible adverse effects.
X-RAY
The monitor will operate with negligible adverse effects in an X-ray
environment. However, the monitor should not be placed directly in
the X-ray beam, which could damage the internal electronics of the
monitor.
OTHER INTERFERENCE
There is a negligible adverse effect to the monitor from electrocautery
and electrosurgery, infrared energy, and defibrillation.
Biocompatibility All patient-contact or user-contact materials in this monitor and it's

accessories have passed ISO 10993-5, -10, & -11 biocompatibility
tests or have been in use in clinical environments in large numbers
over an extended period of time predating these standards.
Latex Content All Criticare Systems, Inc., products, including patient monitors and
accessories, are free from latex in any location that may result in
patient contact.
DEHP Content All Criticare Systems, Inc., products currently shipping are free of
DBP and DEHP in any areas that would be intended for patient
contact with blood, mucous membranes, or continuous skin/tissue
contact.
Section 2 — Service Windows
Service Mode Window The monitor has a Service Mode window that is accessible through
the CONFIG window of the monitor.
! WARNING !
• Never service a monitor while it is attached to a patient.
• Never enter the service menu while monitoring a patient.
Service Mode Window To access the Service Mode located in the CONFIG window:
1. Press the ON/OFF button on the front panel to turn on the
power to the monitor.
2. Rotate the menu knob to highlight CONFIG in the main menu
and press the knob once to select it. The CONFIG window
appears.
EXIT
Date Format MM-DD-YYYY

Date DAY 11 MONTH JUN YEAR 2007
Time 17:47
Freeze timeout 2 minutes
Alarm tone warning ON
Language ENGLISH
Line Frequency 60
Restore Factory Defaults NO
Enter Service Mode NO
Enter Simulation Mode NO
Patient size Adult
Figure 2-1: CONFIG (Configuration) Window

3. Rotate the menu knob to highlight Enter Service Mode and
press to select. The value NO is highlighted.
EXIT

Time 17:47
Language ENGLISH
Line Frequency 60
Patient size Adult
Figure 2-2: Enter Service Mode Highlighted
4. Rotate the menu knob to highlight YES and press to select. The
Enter Service Mode dialog box appears.
Figure 2-3: Password Window for Service Mode

5. To enter the service mode enter the password PIA418 by doing
the following:
• Rotate the menu knob to select a character.
• Press the menu knob to enter each character.
• If a mistake is made, advance to the end of the password and
start over.
When you enter the correct password, the Service Mode
window appears. (See the next step.)
If you entered an invalid password, the window below
appears. Check the validity or spelling of the password you
entered and repeat the password entry.
Figure 2-4: Invalid Password Window
6. When you enter a valid password the Service Mode window

appears:
EXIT
Enter NIBP Service NO

Software Download No action taken
Permanent Alarm Silence Enable
ST / Arrhythmia Keycode ------ Invalid Keycode
Current Software Revisions

Main Display Processor Rev 1.2F
NIBP/CO2/O2 Processor Rev 6.5C
Vital Signs Processor Rev 6.2A
Unit Serial Number 111111111

Unit Part Number 93979AXXX
Keycode Base Number 00000000
Figure 2-5: Service Mode Window
From this point, you can access all service mode functions and
calibrations, set operation values, and perform tests. All the following
functions are accessed from the Service Mode window shown above:
• NIBP Service Mode
• Processor Software Download
• Permanent Alarm Silence
• Arrhythmia and ST Analysis
NOTE: Monitors with CO2 monitoring will have additional items in the
Service Mode window. See “Appendix A – CO2 Service” for CO2
service screens.
NOTE: After you perform each service mode function, you must turn
off power to the monitor. Press the ON/OFF button on the front panel
of the monitor.
NIBP Service Mode From the Service Mode window, do the following:
NOTE: To service the NIBP module you need specified equipment.
See “Section 6: Service Testing and Calibration” for details.
1. To run a high time or pressure test for adults or infants, or to run
an inflate/deflate speed test, with the menu knob highlight Enter
NIBP Service and press to select. The value NO is highlighted.
NIBP Service Mode Parameters window to service NIBP
appears.
Figure 2-6: NIBP Service Mode Parameters Window

3. Rotate the menu knob to highlight the test you want to run and
press to enter. The test value NO is highlighted.
4. Rotate the menu knob to highlight YES and press to begin the
test. When the test is executing, the following message appears
on the bottom of the NIBP service window:
Test in progress, select NO to cancel
5. Press the ON/OFF button to exit the NIBP Service Mode
Parameters window.
NOTE: Pressing the ON/OFF button will turn off the monitor. Press
the ON/OFF button again to restart the monitor.
Processor Software The Software Download parameter in the Service Mode window is
Download used to download software for the following processors:
• NIBP/CO2 Processor
• Vital Signs Processor
• Main Display Processor
From the Service Mode window:

1. Rotate the menu knob to Software Download and press to
select.
2. Rotate the knob to choose the processor you wish to download
and press to select. The value NO is highlighted.
Figure 2-7: Initial Software Download Dialog Box

following window appears:
Figure 2-8: Software Download Response Message

If you choose not to select YES, allow NO to remain selected,
and then press the menu knob to return to the Service Mode
window. The following message then appears next to the
Software Download parameter:
No action taken
4. Press the ON/OFF button on the front panel of the monitor to
turn off the power to the monitor.
Permanent Alarm Silence From the Service Mode window:

1. To disable the permanent alarm silence feature, with the menu
knob highlight Permanent Alarm Silence and press to select.
Enable is highlighted.
2. Rotate the menu knob to highlight Disable and press to select.
NOTE: Read about the override capability of the Permanent Alarm

Silence function over the Alarm Tone Warning function in “Alarm Tone
Warning” on page 2-8.
! CAUTION !
• Before you disable this safety feature, contact your local
distributor because the Permanent Alarm Silence tone is
required in certain countries.
Arrhythmia and ST Analysis The Arrhythmia and ST Analysis software extension has the
capability to measure ST segment deviations and generate
arrhythmia alerts for common ventricle arrhythmia conditions.
The arrhythmia and ST features are available through keycode

activation on all nGenuity 8100E Series monitors. The feature can be
purchased from Criticare Systems, Inc.
NOTE: Unless instructed, DO NOT enter a keycode. In case of

accidentally selecting the keycode, simply turn off the monitor without
completing the keycode entry. The keycode will not be over written
unless you enter the complete keycode.
8100E Series models that do not include the arrhythmia and ST

analysis feature will have the message Invalid Keycode appearing
next to the setting.
Service Settings Several settings on the CONFIG window are password protected. You
should not change these functions during use and only biomed
technicians or supervisory personnel should adjust the settings.
These functions include:
• Alarm Tone Warning
• Line Frequency
• Enter Service Mode
• Enter Simulation Mode
To set the functions listed above, do the following:

1. Rotate the menu knob to highlight CONFIG in the Main menu
and then press the knob once to select it. The CONFIG window
appears.
EXIT

Time 17:47
Language ENGLISH
Line Frequency 60
Patient size Adult
Figure 2-9: CONFIG Parameters window

2. Rotate the menu knob to highlight the service function that you
want and press to select.
Service Password To enter the service mode enter the password PIA418 by doing the
following:
1. Rotate the menu knob to select a character.
2. Press the menu knob to enter each character.
3. If a mistake is made, advance to the end of the password and
start over.
Alarm Tone Warning Set the Alarm Tone Warning value to ON to allow the monitor to
produce a low-pitched double beep every 2 minutes after a new alarm
activates.
Set the Alarm Tone Warning value to OFF to allow the monitor to
suspend any audible alarm (remain silent) after a new alarm
activates. Thus you can silence alarms with a “long” push (held in for
2 seconds) on the monitor’s SILENCE key.
NOTE: As a safeguard measure, the Permanent Alarm Silence

function (Service Mode window) can override the Alarm Tone
Warning function. The Disable value of the Permanent Alarm Silence
function can prevent the ability of the Alarm Tone Warning function’s
OFF value to suspend audible alarms. In this case, pushing the
Silence button has no effect; the monitor’s full audio alarm would
continue. Set this safeguard according to your facility protocols and
according to local safety regulations for medical devices.
Override from the Configuration Window:

Service Mode Window: Alarm Tone Warning
Permanent Alarm
Silence ON OFF
ENABLE double beep always silent
DISABLE full audio alarms full audio alarms
Line Frequency In the CONFIG menu the frequency which is rejected is either 50 Hz
or 60 Hz. Set the frequency to the local AC (mains) power which is 60
Hz in the U.S. and 50 Hz in most of Europe. Contact your local
distributor for more information. The password to change the
frequency is PIA418.
Simulation Mode Simulation software is only used for demonstrations and not intended
for servicing the monitor. The service password is required to activate
this demonstration function. The words SIMULATION MODE appear
in large letters on the monitor screen when in use.
In the sample window shown below, all function parameters are active
and reflected in the waveforms and numerical values that could be
useful for a demonstration or training session. The screen only
displays functions that are available on the unit.
1mV ECG BPM
II SIMULATION MODE
60
20 Br/m
1mV
I 98%
SpO2
1mV
aVL
1mV
aVR
CYCLE OFF
MAP mmHg
---/---(---) AGE --:-- min
ALARMS PARAMS DISPLAY ART1: HIGH DIA

V000 - NO ADMIT
96.4 ºF
ADM/DIS CONFIG PRINT -+ Adult
NOV-07-05 14:12:59
Figure 2-10: Example of the Window in Simulation Mode
NOTE: Simulation Mode can only be exited by pressing the ON/OFF

button and turning off the monitor.
NOTE: To exit the menu, navigate to EXIT and press SELECT.
Custom Profiles The monitor has a set of default settings that you can configure to the
needs of the facility. These default settings are password protected.
Setting Patient Size The monitor is designed to look at the patient size information
selected in the ADM/DIS or ALARMS windows and determine
whether the monitor should use one of the following alarm settings
while monitoring:
• Adult
• Pediatric
• Neonatal
When you change the patient size in the ADM/DIS window or the
ALARMS window, the monitor determines which window appears
when you select the ALARMS window. When the user changes
patient size the user effectively changes all the alarm limits for all of
the following:
• SpO2
• ECG
• NIBP
• Temperature
• Respiration
• Maximum NIBP pressure limit.
To enter patient size, do the following:

1. Rotate the menu knob to highlight ADM/DIS or ALARMS and
press to select.
2. Rotate the menu knob to highlight Update, select YES, and
press to select. You can now select the patient data field.
3. Rotate the menu knob to highlight Patient Size and press to
select.
4. Rotate the menu knob to highlight Adult, Pediatric, or Neonate
as required.
Optional: Enter a value for unit label only if you use central
station communication.
5. Select EXIT to return to the Main window.
6. Exit the ADM/DIS or ALARMS window.
Creating Custom Profiles The default mode you last completed is the default patient size for
custom defaults. If you want a different default size mode, change the
order in which the monitor saves alarm limits.
In the example below, the first patient size setting created is

NEONATE. Update the custom default alarm limits for the pediatric
and adult modes by repeating the steps in this procedure, two more
times, once for PEDIATRIC and once for ADULT as the patient size
setting.
ACCESSING THE DEFAULTS DIALOG BOX

After setting the patient size (e.g., NEONATE), start from the main
window to access and set the defaults for your facility’s custom
profile:
1. Press and hold the DEFAULT button on the front panel for
approximately two seconds. The Set Unit Defaults dialog box
appears.
NOTE: If the Set Unit Defaults dialog box that prompts you to
enter a password did not appear, you did not hold the button in
properly. In this case, with the menu knob highlight and select
CANCEL or you could lose the settings you just created.
2. Enter the password LIA608 by doing the following:
• Rotate the menu knob to select a character.
• Press the menu knob to enter each character.
• If you make a mistake, advance to the end of the password
and start over.
• After you press the menu knob for the last character of the
password, the monitor indicates acceptance of the password
by displaying the Set Unit Defaults window.
• When the Set Unit Defaults window displays, both SELECT
and CUSTOM DEFAULTS are highlighted.
Figure 2-11: Set Profile Before Modifications
ENTERING THE NEW PROFILE TITLE

1. With both SELECT and CUSTOM DEFAULTS highlighted in the
Set Unit Defaults window, rotate the menu knob to highlight
EDIT and press to select.
• As you rotate the menu knob, CUSTOM DEFAULTS remains
highlighted.
• The first letter of CUSTOM DEFAULTS is highlighted.
2. Change the label CUSTOM DEFAULTS (for example, to the title
FACILITY DEFAULTS) by doing the following:
• With the letter C highlighted (the first letter of CUSTOM
DEFAULTS), rotate the menu knob to highlight the letter F
(the first letter of the example FACILITY DEFAULTS) and
press to select. The next letter automatically highlights.
• Continue for the remaining letters of the new title.
• After completing the last letter in the title (in this example, it
would be the letter S), press the menu knob until the entire
label name highlights. This indicates that the entry is
complete but not accepted.
ACCEPTING THE NEW PROFILE TITLE

1. To accept the new label name, rotate the menu knob to highlight
ACCEPT and press to select. The message Action Completed
appears.
Figure 2-12: Set Profile After Modifications

2. Press the menu knob. Your set of defaults are saved in memory.
Section 3 — Theory of Operation
Power Module The 8100E Series patient monitor employs a universal switching
power supply for international use.
In order to monitor the status of the line power, and condition of the
battery pack, the internal power supply circuitry drives several status
lines available to the main module. The power management/
watchdog circuit provides a low battery level detection mechanism
and a hardware-based check on software operation (watchdog timer).
Main CPU and System The microprocessor circuitry handles the Main Board computational
functions and provides integrated I/O functions, including timers, I/O
pins, serial interfaces, and analog I/O.
CONM Module The CONM module contains a microprocessor and associated

circuitry for NIBP. No electrical connection is made with the patient
from the monitor for NIBP. The vital signs parameters are passed to
the main module using a serial channel.
Vital Signs Module The vital signs module is a single printed circuit board with
connectors to the Main Board, the ECG input leads, the SPO2
connector, and the temperature sensor. The vital signs module
contains a microprocessor, and associated circuitry for pulse
oximetry, temperature, ECG signals, and TTI respiration. ECG signals
can be either 3-lead single channel, or 5-lead triple channel. Patient
isolation for galvanic contact is required for the temperature and ECG
functions. Patient isolation for non-galvanic contact is required for the
pulse oximetry sensor. A CAN bus passes the vital signs parameters
to the main module.
The main module sends the vital signs module control information
and the vital signs module sends the main module waveforms and
hardware status. The communication cycle is 20 Hz for the vital signs
information from the VS module, twice a second for the status of the
VS module, and as needed for the control information from the main
module.
Speaker Driver The speaker drive circuit is a DAC controlling speaker volume and an
output pin to control frequency. A software-controlled timer generates
a square-wave signal that drives the speaker. Hence, any drive
frequency has harmonic components, and generates no “pure tones.”
Applicable standards recommend against the use of pure tones in
alarm situations to reduce the risk of an individual with a “notch”
hearing deficit missing an alarm.
ECG Module The ECG module monitors from either three-lead or five-lead surface
electrode configuration, providing one or three concurrent ECG
leadviews, respectively. The ECG module processing includes heart
rate, ECG lost, pacer pulse, and leadoff detection. The main software
is able to control lead, gain/scale, and filter selection, as well as pacer
mode operation. Shielding, both on the PCB and external to it,
reduces the impact of ESU noise on signal quality and heart rate
calculation. The following issues were important in the design of the
ECG module:
• Diagnostic-quality signal bandwidth;
• reliable beat detection and heart rate calculation;
• ESU noise rejection;
• pacemaker pulse detect; and
• artifact rejection
The ECG module uses a differential amplifier to extract surface ECG

activity from a pair of electrodes. Input to the amplifier is protected
against damage from excessive voltages. Passive filtering reduces
high power RF interference from electrosurgical devices. Hardware
under software control performs filtering for monitor vs. diagnostic
modes, lead selection, lead off detection, and pacer pulse detection.
Software performs gain control, notch filtering to remove line
frequency interference, pacer artifact handling, noise detection, beat
detection, heart rate calculation, and serial (CAN bus)
communications.
Impedance Respiration The TTI respiration circuit uses a transformer to generate a low
current, high frequency stimulus through the Lead I electrodes. The
resulting voltage variations reflect impedance variations across the
thorax, which in turn reflect respiration activity (as well as other
phenomena including cardiogenic artifact and motion artifact).
The TTI respiration software performs low pass filtering, high pass
filtering, breath detection, and calculates breath rate.
Pulse Oximeter Module The pulse oximeter is based upon the principle of dual-wavelength
(SpO2) photoplethysmography. Red and infrared LEDs are alternately driven
to illuminate some (relatively well-perfused) tissue site, and a photo
detector receives either the transmitted or reflected light, resulting in
a current flow. This input signal is demultiplexed with sampling in the
monitor to separate the red and infrared components. The
wavelengths are chosen to permit discrimination of oxygenated and
deoxygenated hemoglobin, based on the difference in their
absorbance spectra.
In a “pulse” oximeter, a high-passed AC component is extracted from

each of the red and infrared signals, and digitally processed to detect
the pulsations corresponding to blood flow in the illuminated tissue.
The AC and DC components in red and infrared, measured near the
time of pulsation, are combined in a relatively simple ratiometric
formula (obtained, with many assumptions, by solving Beer’s law
equations with empirically derived coefficients) to yield a figure
proportional to SpO2. The pulse rate is also calculated from the pulse
intervals detected.
Temperature The temperature module measures probe resistance and uses an

internal data table for looking up temperature conversions.
Depending on the user’s selected settings the monitor calculates the
temperature in Fahrenheit or Celsius. The conversion value displays
on the video screen.
Communications The monitor provides two patient-isolated external RS-232 serial data
ports (TX, RX, and ground):
• The DB-9 COM1 port is configured for compatibility with ASCII
printer applications.
• The DIN-8 COM2 port is custom-configured with one pin
reserved for analog output.
The main module drives a patient-isolated external analog output. It

provides a 0 to 1 v output capable of driving a high-level input, such
as a defibrillator or chart recorder.
Printer The Main Board powers and controls the optional printer module. The
Main Board processes error messages from the Printer Board and
displays them on the screen. The internal printer module is a Sieko
LTP1245-type mechanism.
Block Diagram The following block diagram aids in tracing communication and data
routes within the system. Connection numbers are given to show the
relationship between the boards. The diagram is keyed to the theory
of operations found on the previous pages.
SpO2
Cable
J1
SpO2 Board
Connection
External
Module
CRT
Con
P1
Jumper
Temp
P5
P3
Probe
ECG/Analog
(DB-15)
J15
J14
J16
JP1
J17
Board
(Speaker Jack)
Thermistor
J18
Power Nurse
J13
Call Con
Module
J19
Fan
Assembly
P4
J12
P1
P2
J20
Power Speaker
(BNC)
ECG Out
J11
Board
PS2
J2
(DIN 8)
COM2
J10
J1
TP8
Battery
TP6
Main Board
PS1
Connector
Download
ECG
Board
DB9
COM1
TP4
J9
TP2
Solder Side
Pump
P2
(NIBP)
L/N
GND
J1
JTAG Rotary
P1
J8
Isolation Board
Con Component Side Encoder

AC Line
L/N/G
J7
Keypad
Printer
CN1
J1
J6
J3
J4
J2
J5
Board
CN2
CN3
Not Used
Active
LED
Motor
Not Used
Not Used
Backlight
Head
Print
Section 4 — Cleaning and Disinfecting
Cleaning and
! WARNING !
Disinfecting
• Shock Hazard! Before cleaning a monitor and sensor, turn the
power off and disconnect the AC power cable.
• Shock Hazard! Never immerse the monitor because the monitor
has an internal power source that is active even when the unit is
unplugged.
Do not use abrasive cleaners on the monitor or on any sensors or

probes. Abrasive cleaners damage the monitor, sensors, and probes.
With the exception of the display screen, wipe clean the exterior
surface of the monitor with alcohol. Dry it with a soft, dry cloth.
Because paper towels or tissues can scratch the surface of the
display, use a cotton cloth to clean the monitor.
Do not use full-strength alcohol on the display screen. Repeated use

of strong cleaners damages the screen. Clean the display window by
wiping it clean with a soft, lint-free cloth sprayed with common glass
cleaner, however, do not spray glass cleaner directly on the display.
Pulse Oximeter Sensors

! CAUTION !
• Do not immerse any Criticare pulse oximeter sensor connector
in any liquid because it damages the connector.
The SpO2 sensor can be wiped clean with alcohol. Disinfect the SpO2
sensor by placing the paddles and cable in a 2% glutaraldehyde
solution. Only the sensor paddles and cable are placed in the
solution.
Blood Pressure Cuffs You can clean the reusable blood pressure cuff by wiping it with a
damp cloth or sponge. If necessary, disinfect the cuff by wiping it with
70% alcohol, mild bleach solution, or other disinfectant.
Disposable blood pressure cuffs are for single patient use and are not
intended to be disinfected.
You can sterilize the cloth cuff and neoprene bag with commercially
available disinfectants such as ethylene oxide (EtO). Rinse
thoroughly to remove residual disinfectants. Do not allow liquids to
enter the neoprene bag. The cloth cuff can also be sterilized in an
autoclave.
If the cuffs become grossly soiled with blood or other body fluids, you
should launder the cloth cuffs by hand or machine. You can launder
or sterilize the dacron cloth cuff by first removing the neoprene
inflation bag. Feed the inflation tube back through the hole and then
pull out the cloth flap.
Flap
Figure 4-1: Remove Inflation Bag from Cuff
Roll up the inflation bag and slide it out the open slot in the cloth cuff.
The following laundering precautions apply only to non-disposable
cuffs. You should not launder disposable cuffs and neoprene inserts.
• Remove the inflatable bag from the cuff before laundering or
sterilizing the cuff.
• Close the Velcro® fastener before you launder the cuff.
• Strong bleach solutions damage the cuff.
• Temperatures over 275° F (135° C) damage the cuff.
• Soaking the cuff in dark-colored solutions may stain or discolor
the cuff.
Hand laundering (as opposed to machine laundering) prolongs the

life of the cuff. Wash the cuff in warm, soapy water. Rinse the cuff
thoroughly. After you clean the cuff, allow the cuff to air dry, then
insert the inflation bag in the cuff.
ECG Cable You can clean the ECG cable and leads with alcohol. Do not immerse
the connections.
Temperature Cable Clean the cable according to the hospital protocol for cleaning of
reusable equipment cables.
Typically this protocol consists of the following steps:

1. Disconnect the cable from the monitor and temperature sensor.
2. Wipe the cable with a nonabrasive cloth moistened with a mild
detergent and warm water or a disinfectant.
3. Dry thoroughly.
4. Do not use alcohol or solvents to clean the cable.
5. Do not allow the cable connectors and contact points to come in
contact with liquids.
6. Do not fully immerse the cable in liquids.
7. Do not autoclave or EtO sterilize the cable.
Accidental Wetting ! WARNING !

• Shock Hazard! Because a monitor is an AC-powered
device, an immersed monitor presents a danger to
anyone who attempts to handle the device.
Immediately perform the following steps following an accidental

wetting of equipment:
1. Turn the power off. Disconnect the AC power cord from the
monitor.
2. If the monitor is monitoring a patient, transfer the patient to
another monitor as quickly as possible.
3. Use a clean, dry towel or cloth to remove the liquid from the
monitor housing.
4. A service technician should inspect the monitor as soon as
possible.
5. If the internal mechanism is saturated, allow the liquid to drain
out for 24 hours before shipping.
6. If liquid has entered the monitor, it must be dried and cleaned
internally. Full testing is required before you can use the
monitor. Contact the CSI service department as soon as
possible.
Time is critical. The longer any liquid remains in the monitor, the
more damage it can do. It is important to service the monitor
immediately after any liquid is spilled into it.
Section 5 — Preventative Maintenance
Incoming Inspection You must inspect monitors coming back from service for shipping
damage before you place them into operation just like newly
purchased monitors. The monitor should be free from dents, cracks,
or other physical damage. The quality inspection seal of the monitor
should be unbroken, indicating that the monitor has been tested
according to manufacturer’s specifications.
If further incoming inspection or testing is required, the manufacturer

recommends that you use the Alarms Verification (located in this
section) as an incoming inspection test. You can perform additional
electrical safety testing in this section as part of an incoming
inspection in accordance with the policies of the health care provider.
Maintenance Schedule
Every Patient • Clean and disinfect the sensor cables and sensor.
• Inspect the accessories and cables for damage.
Every Day • Charge the monitor’s battery.
Every 3 Months • Clean the exterior of the unit (or clean as needed).
Every Year • Perform the annual safety tests provided in this section.
NOTE: For additional maintenance of the CO2 module, see

“Appendix A – CO2 Service.”
Monitor Safety Testing You can perform the following tests as part of a periodic safety check.
The following safety tests are designed so that the monitor’s warranty
seal does not have to be broken. If the monitor fails any portion of
these tests, contact the CSI service department.
The contents of this section, “Preventative Maintenance,” include the

following verifications and safety tests:
• Withstanding Voltage (Hi-Pot)
• Electrical Leakage
• Ground Continuity
• Interface Inspection
• Manual Controls Check
• Alarm Verification
• Vital Sign Modules Verification
• ECG
• SpO2
• NIBP
• Temperature
• Internal Printer
• Communications
• Battery and Power
Criticare recommends that you run a serviced monitor for 24 hours

before you perform the tests listed above and place the monitor back
into service.
Repaired modules could require more extensive testing than what is

shown in this list.
Always follow ESD precautions when performing a procedure

discussed in this section.
! WARNING !
• Because test procedures require working with exposed

electrical circuits, only experienced electrical or biomedical
technicians should perform the procedures.
• After a monitor is altered through repair or hardware
adjustment, you must fully test it before use.
Equipment and Tools The following procedures assume that the technician has an ESD
safe workbench, a set of electronic hand tools, and a digital
multimeter with a 10 amp setting. At the beginning of each test,
special equipment can be listed. A variety of customized cables, clips,
and test fixtures are also needed to complete the tests. For more
information, contact the CSI Service Department.
Accessory Testing Check patient cables (e.g., temperature cables, printer cables)
monthly for damage, loose wires/connections, loose connectors,
cracked housing, etc.
Check the electrical safety of the power cord as part of the monitor
safety testing.
Check the cuffs for leakage as part of the NIBP verification.
Fuse Removal/ There are two (2) AC power fuses located at the rear of the monitor
Replacement directly below the AC power entry socket.
• United States monitors use 1A 250V Time Lag fuses.
• International monitors used in 220-240 volt environments use
1A 250V Time Lag fuses.
1. Remove power cord.
2. Press in the side clips (at the same time) with a tool and lift out
the access cover. The two (2) fuse sockets are visible
Clips
Figure 5-2: Remove the Fuse Cover
Figure 5-3: Fuses Exposed
3. Gently pull the fuses out of the fuse cover assembly.
Figure 5-4: Fuses Pulled

4. Reassemble in reverse order.
For more information about troubleshooting power problems, refer to

“Troubleshooting” in Section 8.
Long-Term Monitor No special preparation is necessary for long term storage of the
and Battery Storage monitor. Although you do not have to remove the battery from the
monitor for long term storage, the battery drains to an unrecoverable
state after 3 months without periodic charging.
Monitor and At the end of its useful life, you can dispose of the monitor and its
Accessories Disposal accessories according to your institution’s policies and procedures for
disposal of patient-contact medical waste.
Alternately, you can return the monitor and its accessories to

Criticare Systems, Inc., for safe disposal. The shipping address is:
Criticare Systems, Inc.

20925 Crossroads Circle, Suite 100
Waukesha, WI 53186
Electrical Safety Perform this test each time you open the monitor housing and before
Testing you use the monitor on patients.
! WARNING !
• Shock Hazard! Because dangerous and lethal voltages are
present during the withstanding voltage, leakage, and ground
continuity test, all leakage and voltage testing must be done
with the monitor housing in place. For complete information
about the proper operating and safety procedures, refer to the
nGenuity 8100E Series Patient Monitor Operator’s Manual.
Equipment Needed The following are needed to complete this procedure:

• Kikusui TOS 8750 Withstanding Voltage Tester (or equivalent
Hi-Pot tester)
Withstanding Voltage The following test and set-up is for the Kikusui TOS 8750
(Hi-Pot) Test Equipment Withstanding Voltage Tester. If you use an equivalent tester, use the
and Setup factory recommended test for that tester.
1. Test the Withstanding Voltage Tester by connecting the red and
black lead together. Set the voltage to 1000 VAC.
2. Set timer for 1 second and cutoff current for 1 milliamp.
3. Press the Test button. The NG light should come on.
! CAUTION !
• If the NG light does not come on, do not continue with this test.
You must repair or replace the withstanding voltage tester.
Withstanding Voltage NOTE: For the following tests set the Hi-Pot unit as follows:
(Hi-Pot) Test Procedure
Memory #20 Memory #21
Arc Fail OFF OFF
Arc Sense 5 5
Ramp-HI OFF OFF
Charge LO 0.0 µA 0.0 µA
Dwell Time 1.0 sec. 1.0 sec.
Ramp Time 1.0 sec. 1.0 sec.
LO-Limit 0.0 µA 0.0 µA
HI-Limit 1000 µA 1000 µA
Voltage 2.500 KV 4.242 KV
1. Connect the red lead of the Hi-Pot to Hot/Neutral and the black
lead to Chassis Ground (EPT). Set up the Hi-Pot per table
above to Memory #20. Verify Hi-Pot is now set to a Trip Current
of 1mA and test @2500VDC for 1 second.
lead to ECG. Set up the Hi-Pot per table above to Memory #21.
Verify Hi-Pot is now set to a Trip Current of 1mA and test
@4242VDC for 1 second.
lead to Temperature. Set up the Hi-Pot per table above to
Memory #21. Verify Hi-Pot is now set to a Trip Current of 1mA
and test @4242VDC for 1 second.
lead to SpO2. Set up the Hi-Pot per table above to Memory #21.
lead to BNC. Set up the Hi-Pot per table above to Memory #21.
@2500VDC for 1 second
lead to Nurse Call. Set up the Hi-Pot per table above to Memory
#21. Verify Hi-Pot is now set to a Trip Current of 1mA and test
Leakage Test Equipment Perform all testing with the cover on. The following test requires a
and Setup Dynatech 232D leakage tester or equivalent.
1. Perform a self-test, if applicable, on the DYNATECH 232D by
plugging it into 110 VAC outlet. Turn on the leakage tester. Set
the mode switch to self test. Display should read 1000 ±20 and
the CURRENT SOURCE ACTIVE lamp should be on.
! CAUTION !
• If these conditions are not met, do not continue with this test.
2. Set the mode switch on the Dynatech 232 to L1-L2 (line
voltage). The display should read the line voltage ±10%. Set the
mode switch to L1-GND. The display should read no more than
5% of L1-L2 on a grounded power system. Set the mode switch
to L2-GND.
NOTE: This should read about the same as the L1-L2 reading
for a grounded system.
Leakage Test Procedure The monitor must be powered up during all of the isolation tests.
1. Set the mode switch on the Dynatech 232 to L1-L2. The display
should read the line voltage ±10%. Set the mode switch to L1-
GND. The display should read no more than 5% of L1-L2 (line
voltage) on a grounded power system. Set the mode switch to
L2-GND. This should read about the same as the L1-L2 reading
for a grounded system.
2. Turn the mode switch to CASE LEAKAGE GROUND
CONDUCTOR. Connect the AC cord from the Dynatech 232D to
the 8100E(P) and turn on the unit. With the POLARITY switch in
the NORMAL position, Press OPEN GROUND and monitor the
readout for less than 500 µA.
Verify that the green AC LED lights up on the front membrane.
NOTE: The 8100E Series monitor must be powered up during

all of the isolation tests.
3. Change the polarity switch to the REVERSE position, press
OPEN GROUND and monitor the meter for less than 500 µA.
4. With the POLARITY switch in the NORMAL position, press
OPEN NEUTRAL and OPEN GROUND switches and monitor
the meter for less than 1 mA.
5. Change the POLARITY switch to the REVERSE position and
press the OPEN NEUTRAL and OPEN GROUND switches and
monitor the meter for less than 1 mA.
6. Connect a Dynatech 232 or equivalent to the 8100E Series

monitor using the 5 lead ECG cable marked Cat 1075/S.
Change the MODE switch to ECG. For the rest of the Leakage
test insure that the leads are dressed away from the ground
planes and the AC power cords and the chassis. Set the LEADS
selector switch to ALL TO GND. Set the POLARITY switch to
NORMAL. Monitor the meter for less than 5 µA.
7. Set the POLARITY switch to REVERSE and monitor the meter
for less than 5 µA.
8. Set the POLARITY switch to NORMAL and press the OPEN
NEUTRAL switch and monitor the meter for less than 10 µA.
9. Set the POLARITY switch to REVERSE and press the OPEN
NEUTRAL switch and monitor the meter for less than 10 µA.
10.Set the POLARITY switch to NORMAL and press the OPEN
GROUND switch and monitor the meter for less than 10 µA. For
inline voltages of 264V, meter for less than 20µA.
11.Set the POLARITY switch to REVERSE and press the OPEN
GROUND switch and monitor the meter for less than 10 µA. For
inline voltages of 264V, meter for less than 20µA.
12.Turn the LEADS selector switch to the ISO Position. Turn the
POLARITY switch to NORMAL, press the ISO TEST button, and
monitor the meter for less than 20 µA. For inline voltages of
264V, meter for less than 50µA.
13.Keep the power cord plugged into the unit under test and the
Dynatech. Unplug the 8100E Series ECG cable from the 8100E
Series monitor. Unplug the ECG test leads from the Dynatech.
Connect the SpO2 cable end to any of the BROWN ECG test
terminals on the Dynatech. Connect the other end to the SPO2
connector on the monitor under test. MODE switch should be on
ECG. Change the LEADS switch to ISO. Set the POLARITY
switch to NORMAL. Press the ISO button and monitor the meter
for less than 20 µA. For inline voltages of 264V, meter for less
than 50µA.
14.Keep the power cord plugged into the monitor under test and
the Dynatech. Unplug the SpO2 cable from the 8100E Series
monitor. Unplug the test leads from the Dynatech. Connect the
Temp cable end to any of the BROWN ECG test terminals on
the Dynatech. Connect the other end to the TEMP connector of
the monitor under test. MODE switch should be on ECG.
Change the LEADS switch to ISO. Set the POLARITY switch to
NORMAL. Press the ISO button and monitor the meter for less
than 20 µA. For inline voltages of 264V, meter for less than
50µA.
15.Verify the green AC LED lights up on the front membrane.
Ground Continuity Test This portion of the test requires a ROD-L Model 25 Ground Continuity
Tester, or equivalent.
Do the following before turning on the ground tester:

1. Set the ground continuity tester to the resistance trip point
setting of 0.1 ohms.
2. Set test time of 6 seconds. Set the tester to ground test only. Set
the test current to 25 AMP’s.
3. Turn on the ground tester.
4. Plug in the AC cord from the ground continuity tester to the
monitor being tested.
5. Connect the ground cable to the chassis ground on the rear of
the monitor.
6. Press the Reset button on the tester. Press the Start button.
7. The monitor passes if the Fail Light does not come on or if the
resistance does not exceed 0.1 ohms during the test.
Functional Testing
Interface Inspection This procedure is for the monitor’s TFT active display.
1. Verify that a readable screen displays. For a guide to proper
screen layout, refer to the nGenuity 8100E Series Patient
Monitor Operator’s Manual for sample screens.
2. Verify that the screen display is clear and bright when you
directly face the monitor.
Manual Controls Check 1. Verify that rotating the menu knob moves the cursor through the
menu items. Verify that when you press the menu knob on a
highlighted menu item the monitor displays a sub-menu.
2. Use the menu knob to enter the CONFIG window and set the
date and time for the real time clock.
3. Press the FREEZE key. Verify that you get an audible response
from the speaker. Press the FREEZE key again to unlock the
waveforms.
4. Press the TREND key. Verify that you get an audible response
from the speaker. A Trend window appears on the display. Press
the TREND key again to close the Trend window. (Or optionally,
press and hold the TREND key to open the TYPE/INTERVAL/
SCREEN menu that you close by selecting EXIT.)
5. Press the STANDBY key. Verify that you get an audible
response from the speaker. A standby confirmation menu
should appear. Highlight NO and press menu knob to exit.
6. Press the DEFAULT key. Verify that you get an audible response
from the speaker. The Custom Default menu appears. Select
CANCEL and then press menu knob when No action taken is
highlighted to exit.
Alarms Verification To verify the alarm circuitry for SpO2, perform the following
procedure.
1. In the PARAMS window turn off all monitoring modules except
for SpO2. Set the display to show a plethysmograph waveform.
2. In the PARAMS window set the SpO2 Low Limit Alarm setting to
HIGH. This sets the alarm priority for only this alarm parameter.
3. Use an SpO2 simulator to set the monitor to display the
plethysmograph waveform. Confirm the heart rate and
saturation reading.
4. In the ALARMS window adjust the SpO2 low alarm level above
the saturation reading to cause an alarm condition.
5. Verify that the message LOW SPO2 appears at the top of the
waveform channel in red letters.
6. Verify that you get an audible response. The alarm should be a
high priority alarm tone consisting of 3 beeps followed shortly by
two beeps.
7. In the PARAMS softkey window, change the SpO2 Low Limit
Alarm setting to MEDIUM.
8. Verify that the message LOW SPO2 appears at the top of the
waveform channel in yellow letters.
9. Verify that you get an audible response. The alarm should be a
medium priority alarm tone consisting of 3 beeps.
ALARM VOLUME TEST

1. From the ALARMS window, vary the ALARM VOLUME through
the ranges, from OFF to 10. Verify that the speaker volume
changes according to the setting of the ALARM VOLUME.
2. Press the alarm SILENCE key once. Verify that the low heart
rate alarm stops for 2 minutes and that the 2-minute Alarm
Silence icon appears in the system status area of the screen.
3. Press and hold the alarm SILENCE key for at least 2 seconds.
Verify that the low heart rate alarm stops and the Alarm
Suspend icon appears in the system status area of the screen.
Printer Check The printer only prints if the green battery light is ON or the AC
(mains) cord is plugged in.
1. Lift the paper feed lever up and insert paper. Close the lever and
the paper should automatically feed.
2. In the PRINT window, set the Print Type to “Tabular.” Press the
PRINT key on the front of the monitor.
3. Verify that the correct date and time print.
Module Verification
ECG Verification This test requires a Dynatech Nevada Model 300 simulator, or
equivalent.
1. Select the menu to set up for ECG PARAMS to 5-Lead, ECG
ON, Filters: MONITOR, SENSITIVITY to HIGH.
2. Insert a shorted ECG cable into the ECG connector. Use the
menu knob to enter the DISPLAY window. Set the following and
use the current defaults for the size. They are 25MM except
waveform 3:
• Waveform 1 ECG I x 4.0 25.0
• Waveform 2 ECG II x 4.0 25.0
• Waveform 3 ECG V x 4.0 25.0
3. Exit the DISPLAY window. Verify that the baselines are
centered. Verify that the base line signal is no greater than 3
pixels in height. Select the most solid line as the reference line
and verify that this reference is less than ±3 pixels from the ECG
y-axis center line. If they are not, adjust pots R12 (Waveform 1),
R110 (Waveform 2) and R108 (Waveform 3). Remove the
shorted cable.
4. Verify that the message LEADS OFF appears at the top of the
window when no cable is connected.
5. Connect the 3-lead ECG patient cable CAT 1075/S to the ECG
cable assembly, and use a Dynatech Nevada Model 300
simulator to turn on (ECG) normal sinus, 60BPM, amp 1.0mV,
axis int. Respiration rate 20, and the impedance set for 0.5
ohms, and base impedance for 2K.
6. Rotate the menu knob to select PARMETERS and press to

enable the menu. Select ECG for (3 LEADWIRE). Set the
monitor for LEAD II waveforms.
Check the following lead configurations for following items:
• heart rate 60 ±3 BPM,
• RESPIRATION RATE of 20 ±2 breaths per minute and
• correct waveform.
7. Use the Electrode status error messages on the CRT to perform

a lead off check in LEAD II.
a. (LL) Red LL LEAD OFF
b. (LA) Black LEADS OFF
c. (RA) White RA LEAD OFF
8. Connect all the leads back on the simulator and select ECG to
5-lead. Set the monitor for LEAD II waveforms. Disconnect the
following leads one at a time and look for the proper status error
message and for the waveform to continue or flatline.
Reconnect the lead and the message should disappear and the
waveform should return, if it flatlined.
a. (V1) Brown V LEADS OFF
b. (LL) Red LL LEADS OFF
c. (LA) Black LA LEADS OFF
d. (RA) White RA LEADS OFF
e. (RL) Green LEADS OFF
9. Check the following lead configurations for following items:

• Heart rate 60 ±3 BPM,
• resp. rate 20 ±2 BPM and
• correct waveforms.
III
10.Verify that the respiration rate changes from 20 to 30bpm, when

changing on the MED SIM 300.
11.Rotate the menu knob to highlight Display and press to select.

Under waveforms 3-6, Select:
• RESP as TYPE,
• GAIN as 1.0,
• SWEEP as 25MM/SEC and size.
The size might not be changeable on some waveforms. Select
Exit and verify that a non symmetrical sine wave displays on the
window.
12.Set the Dynatech MED SIM300 to a heart rate of 300BPM.
Verify that the ECG HR reads 300BPM ±1BPM.
13.Turn off the simulator and verify that the message ECG LOST
appears at the top of the window.
14.Turn the simulator back on and set the simulator for 60BPM,
LEAD II and verify that the gain settings are effective at x.5, x2,
and x4 for 1mv ECG input.
15.Select on the simulator for ECG performance. Cursor through
the menu until you obtain and execute twice the PACED
RYTHMS. Verify that PACE is turned on in the menu screen of
the 8100. You should see white spikes on the waveform and
75BPM.
16.Select ECG on the simulator, select base, then BPM, and 60.
This gives a normal sinus rhythm at this time. Select ECG, then
ARRH, then VNT2, and then VFIB. The unit should detect an
erratic baseline and display the message ECG LOST.
ECG Analog Output Test You need a MedSim 300 patient simulator to perform this procedure.
1. Connect a BNC cable with 0.1uf CAP signal-to-ground from the
ECG BNC on the monitor to an input channel on an
oscilloscope.
2. Select and press the PARAMS softkey.
3. Set Filter to Diagnostic and ECG Sensitivity to Medium.
4. Select and press the DISPLAY softkey.
5. Set Waveform 1 for ECG Lead II (ECG II) on the screen.
6. Set the MedSim 300 patient simulator for “tri s10” (triangle
waveform).
7. Verify that the baseline is zero and signal is a peak-to-peak
voltage of 1.2V (±0.2).
Diagnostic, Monitor, and 1. In the PARAMS menu, set FILTER to DIAGNOSTIC. On the
ST Filter Mode Tests simulator, select PERF under ECG, then WAVE, and then "s10"
(10 Hz sine wave). Verify on the monitor that the S40 simulator
sine wave signal displayed has amplitude no less than 0.95 X
“s10” (10 Hz sine wave). To accomplish this, measure the peak-
to-peak amplitude of the 10 Hz sine wave in waveform, then
measure the peak-to-peak amplitude of the 40 Hz sine wave.
There shall be no more than a 5% decrease (40 Hz amplitude =
or > 0.95 X 10 Hz amplitude).
2. Select MONITOR filtering. The 40 Hz sine wave displayed on
the monitor display shall be 0.70 X the input amplitude in mV
when the simulator is set to “s10” (10 Hz sine wave). Measure
as described in the previous step.
3. Select ST filtering. The 40 Hz sine wave displayed on the
monitor shall be 0.70 X the input amplitude when the simulator
is set to “s10” (10 Hz sine wave). Measure as described in the
previous step. Set FILTER back to DIAGNOSTIC.
4. On the simulator, use the > arrow to select "s0.05" for a 0.05 Hz
sine wave. In the monitor's DISPLAY menu select a sweep
speed of 12.5 mm/sec. The 0.05 Hz sine wave shall be 0.70 X
the input amplitude as displayed on the monitor when the
simulator is set to “s10” (10 Hz sine wave). Measure as
described in the previous step.
5. Select MONITOR filtering. The 0.05 Hz sine wave is no longer
present (flat baseline). On the simulator, select “s0.5” (0.5 Hz
sine wave) and verify that a 0.5 Hz sine wave with amplitude
equal to 0.70 X the 10 Hz sine wave amplitude is present. Set
the simulator back to “s0.05”.
6. Select ST filtering. The 0.05 Hz sine wave should have an
amplitude equal to 0.70 X the 10 Hz sine wave amplitude. Set
the FILTER back to DIAGNOSTIC. Select 10Hz on the
simulator.
7. Turn off the simulator, Verify that the message ECG LOST
appears at the top of the screen.
SpO2 Verification The following test requires a SmartSat SpO2 analyzer. If you service
the monitor (i.e., you open the housing), use the longer SpO2
Performance test. For more information, refer to “DOX SpO2
Performance Testing” on page 6-3.
NOTE: For older revision SmartSat analyzers that do not have a

Model 8100 selection, use the general Criticare selection in the
SmartSat simulator. Check the SpO2 value of 52% (±3%) with the
analyzer set to 42%.
1. Verify that the message SPO2: NO SENSOR appears when
there is nothing connected to the SpO2 connector.
2. Verify that the message SPO2: HIGH AMBIENT appears by
introducing a higher than normal amount of ambient light on the
SPO2 sensor detector. Verify the message disappears within 10
seconds after you remove the ambient light.
3. Verify that the message SPO2: SENSOR appears when you
plug the finger sensor in, but without a finger actually inserted
into the sensor.
4. Use an SpO2 finger sensor and verify that the heart rate and
plethysmograph operation display on the LEDs within 15
seconds. Verify that SpO2 error messages do not appear (alarm
violations can occur depending on individual readings and
monitor set-up).
5. Verify the LCD displays a plethysmograph waveform. Connect
cable CAT 931A to COM2. Plug BNC-A of the cable into a
oscilloscope channel. In the CONFIG window, ANALOG OUT
SELECT, select PLETH. Use the SpO2 finger sensor to verify
that the SpO2 waveforms appear on the scope. The waveform
should be centered on 0 volts and register 1 volt peak-to-peak.
Remove the CAT 931A cable.
6. Verify that the pulse tone increases as you change the tone from
1 to 10 in the Alarm Setting window.
7. Use an optical load to simulate a small signal and verify that the
message SPO2: SEARCH or LOST appears after search delay
time ± 5 seconds. (An optical load that can be used for this test
is a foam peanut used for packing.)
NIBP Verification The NIBP verification requires Dynatech Nevada NIBP Analyzer, or
equivalent.
Connect the 8100E Series monitor to a Dynatech Nevada NIBP

Analyzer set for the following operation.
NIBP Analyzer Settings
Adult 120/80 (90); Heart Rate 80 bpm
Neonate 80/50 (62); Heart Rate 80 bpm
Pressure Adjustments: Gain 100%; Shift 4
1. Use the T-connection with the dummy cuffs for these tests.
Connect them to the 0-300 mmHg port of the NIBP analyzer.
2. Connect the monitor to an AC (mains) power source and turn on
the monitor.
3. Press the monitor’s NIBP CYCLE/STAT key. The monitor’s cycle
time window appears.
4. Select the NIBP Cycle Time to two minutes.
120/80 OPERATION SETTING

1. In the monitor’s ADM/DIS window set the Patient Size to Adult
mode.
2. Connect the NIBP hose to the fitting on the monitor.
3. Press and hold the NIBP key.
4. Allow the monitor to take at least four (4) readings. Calculate the
average of the four (4) readings and verify that each reading
does not vary by more than ±4% or ±4mmHg (whichever is
greater) from the calculated average. Each reading shall not
vary more than 8 mmHg from the simulator setting.
5. Recalibrate the monitor if necessary.
80/50 OPERATION SETTING

1. Set the monitor to the Neonate mode.
2. To verify STAT mode operation, press and hold the NIBP
CYCLE/STAT key.
3. Allow the monitor to take at least four (4) readings. Calculate the
average of the 4 readings and verify that each reading does not
vary by more than ±4% or ±4mmHg (whichever is greater) from
the calculated average. Each reading shall not vary more than 8
mmHg from the simulator setting.
Temperature Verification This section requires the use of a Fogg TP400/700 simulator. This
simulator is available from Fogg Company Systems, Inc. Or an
equivalent simulator may be used.
1. Select Temperature ON from the PARAMS window and TEMP
F/C: (Centigrade). Connect the temperature to TEMP on the
monitor. Insert the simulator (TP 400).
2. Verify that simulator settings correctly display for all
temperatures that range from 20° C to 45° C with accuracy of
±0.1° C.
3. Verify that the message TEMP INVALID appears when the
temperature is at 0 for TEMP.
4. Select Temperature ON from the menu setup and TEMP F/C:
(Centigrade). Connect the temperature to TEMP on the unit.
Insert the simulator (TP 700).
5. Verify that simulator settings correctly display for all
temperatures that range from 20° C to 45° C with accuracy of
±0.1° C. Verify that TEMP INVALID appears when the
temperature is at 0.
Communication Testing
Nurse Call This test requires the use of a Nurse Call fixture. This fixture may be
created by using the schematic below:
!LLIGATORCLIPSTO
CONNECTTOBATTERY v-INISTEREOPLUG
* $ $ $ $ *
6"ATT0OS *PINSAND

,%$ ,%$ ,%$ ,%$
#/. 6"ATT.EG * #/.
1. Connect the Smart Sat and monitor all levels.

2. Connect the Nurse Call fixture into the back of the monitor while
the Smart Sat simulator runs.
3. Create an alarm state with the Smart Sat, and verify that the
lights on the Nurse Call fixture go on.
4. Press the Alarm Silence button, and verify that 2 minutes
appears at the top of the display and the lights on the Nurse Call
fixture go off and remain so for two (2) minutes while the in the
alarm state.
5. Press and hold the Alarm Silence button. The Nurse Call fixture
should go off and remain off regardless of changing alarm
states.
NOTE: While in the 2 minute Alarm Silence, if the alarm states

change, the Nurse Call fixture lights will come back on. While in
permanent alarm silence, the lights on the Nurse Call fixture
should remain off regardless of changing alarm states.
Battery and Power This procedure provides a method of testing the power regulation and
Testing battery charging circuits of the main board. This test does not require
you to open the monitor housing and break the warranty seal.
! WARNING !
• Shock Hazard! Do not attempt to power the monitor with an
external DC source, while sensors are attached to a person.
Always use vital signs simulators when using alternate power
sources during testing.
• If voltages exceeding those listed are applied, permanent
damage will occur.
Test the Battery 1. Set a power supply to 13VDC (±0.25VDC). Attach the power
supply module to the battery terminals of the monitor under test.
Turn on the monitor under test and verify that the green battery
icon is present.
2. Lower the voltage with the adjustment of the power supply to a
voltage of between 11.55 and 11.40 VDC and verify a yellow
battery icon appears.
3. Lower the voltage to between 11.30 and 10.50 VDC and verify
that a black battery icon appears.
4. Continue to decrease the voltage and verify that the unit shuts
down at 10.2 VDC (±0.5VDC).
Functional and Safety

Testing Checklist
Functional and Safety Testing Checklist (Page 1 of 2)
SERIAL NUMBER ______________________________
Tester_____________________ DATE ______________
SOFTWARE REV. MAIN_______ SOFTWARE REV. CONM_______ SOFTWARE REV. VSM _____
PASS FAIL
Verify 1 Amp fuses ______ ______
Verify Ground Continuity ______ ______
Verify Hi-Pot:
Hot/Neutral to EPT @ 2500VDC ______ ______
Hot/Neutral to ECG @ 4242VDC ______ ______
Hot/Neutral to Temperature @4242VDC ______ ______
Hot/Neutral to Spo2 @4242VDC ______ ______
Hot/Neutral to BNC @2500VDC ______ ______
Hot/Neutral to Nurse Call @2500VDC ______ ______
Verify Leakage:
Self test 1000 ± 20 ______ ______
Line voltage on Dynatech 232 ______ ______
Case leakage GND Con Ext. OPEN GND NORMAL<500µA ______µA _____µA
Case Leakage GND CON OPEN GND REVERSE <500 µA ______µA _____µA
Open Neutral Open GND Normal <1mA ______µA _____µA
Open Neutral Open GND Reverse <1mA ______µA _____µA
ECG Mode to GND Normal <5UA ______µA _____µA
ECG Mode to GND Reverse <5UA ______µA _____µA
Open Neutral Normal < 10UA ______µA _____µA
Open Neutral Reverse <10uA ______µA _____µA
Open GND Normal <10uA for 120V input
(<20µA if line voltage is 264V) ______µA _____µA
Open GND Reversed <10µA for 120V input
(<20µA for 264V line voltage) ______µA _____µA
ISO test ECG Normal <20µA for120V input
(<50µA if line voltage is 264V) ______µA _____µA
ISO test SPO2 Normal <20µA for 120V input
(<50µA @ 264V line voltage) ______µA _____µA
ISO test Temp Normal <20µA for 120V input
(<50µA @ 264V line voltage) ______µA _____µA
Verify AC light is on ______ ______
Verify that the SPO2 Smart Sat is operational ______ ______
Verify that Nurse Call is operational ______ ______
Verify that Alarm Volume is increases ______ ______
Verify 2 min ALARM SILENCE ICON ______ ______
Verify ALARM OFF ______ ______
Verify correct software revision ______ ______
Verify correct serial number and software ______ ______
Connect to computer using COM 1 ______ ______
Connect download cable ______ ______
Cal 0 for NIBP ______ ______
Verify communication with Calibration Program ______ ______
Accepted calibration for 0 ______ ______
Accuracy readings are within 2% or 3 in. hg. ______ ______
Verify the Speed Test (12-15 s inflate, <10 s deflate) ______ ______
Verify that the Leak Test < 4mmHg/min ______ ______
Timeout for Adult ______ ______
Verify Leak Test Neonate (<4mmHg/min) ______ ______
Verify timeout Neonate ______ ______
Safety Test Adult ______ ______
Safety Test Neonate ______ ______
Adult Reading on 2 min (4 readings) ______ ______
______________ ______________ ______________ ______________
Neonate Reading on STAT MODE (4 readings) ______ ______
______________ ______________ ______________ ______________
Functional and Safety Testing Checklist (Page 2 of 2)

PASS FAIL
Monitor powers up on Battery only ______ ______
ON Current Base < 1400mA ______ ______
Verify that charging works on BATT ______ ______
Verify GREEN BATTERY ICON ______ ______
Verify YELLOW BATTREY ICON ______ ______
Verify BLACK BATTERY ICON ______ ______
Verify SHUTDOWN @ 10.0 (± 0.5) VDC ______ ______
If active is connected, full view is readable ______ ______
Verify that the display meets the criteria ______ ______
Verify SPO2 NO SENSOR ______ ______
Verify SPO2 HIGH AMBIENT ______ ______
VerifySPO2 SENSOR ______ ______
Verify SPO2 Readings with HR ______ ______
Verify PULSE TONE ______ ______
Verify SPO2 SEARCH OR LOST ______ ______
Verify Temp Accuracy 20 to 45 degrees C TP400 ______ ______
Verify Temp Accuracy 20 to 45 degrees C TP700 ______ ______
Verify Temp INVALID for both ______ ______
Verify baselines are set @ x4 and no more than 3 pixels ______ ______
Verify LEADS OFF message ______ ______
Verify 3-Lead operation for LEAD I, II, III,
verify 60bpm and 20bpm for respiration ______ ______
Correct leads off message in Lead II ______ ______
Correct Lead off messages for five lead ______ ______
Verify 5-lead operation for I, II, III, AVL, AVR, AVF, V ______ ______
Verify Respiration @ 20 BPM ______ ______
Verify Respiration waveform ______ ______
Verify the HR @300 BPM ______ ______
Verify that the gain works @. 5mv, 2mv, & 4mv ______ ______
Verify Pace detect is functional @ 75BPM ______ ______
Verify ECG LOST is detected from VFIB ______ ______
Verify that ECG out works from J11 ______ ______
Verify Sine wave < 5% decrease ______ ______
Verify sine wave in Monitor Mode ______ ______
Verify sine wave in ST filtering ______ ______
Measure the sine wave @.05Hz ______ ______
In Monitor mode @ .5Hz ______ ______
Verify ST mode @.05Hz ______ ______
Verify ECG LOST when the simulator is turned off ______ ______
Verify encoder works ______ ______
Verify time & date are set ______ ______
Verify that FREEZE button is operational ______ ______
Verify that the TREND button works ______ ______
Verify that the STANDBY button works ______ ______
Verify that the DEFAULT button works ______ ______
Verify that printer paper feed works. ______ ______
Verify that printer is operational ______ ______
Verify external monitor is functional ______ ______
Verify that serial number is correct ______ ______
Verify all hardware is tight and properly sealed ______ ______
CERTIFICATION THAT THE UNIT IS FUNCTIONING PROPERLY.

NAME ___________________DATE_________________________________________
CERTIFICATION OF FUNCTIONAL AND SAFTEY TESTING

TECHNICIAN ______________________________________DATE______________
This checklist may be copied as needed to record field testing
Section 6 — Service Testing and Calibration
Field Service Testing
Safety ! WARNING !
• Service testing procedures require working with exposed
electrical circuits and should only be attempted by experienced
electrical or biomedical technicians.
• When a monitor is altered through repair or hardware
adjustment, it should be fully tested before use.
! CAUTION !
• Always follow ESD precautions when performing any procedure
discussed in this section.
• The manufacturer recommends that a serviced monitor be
allowed to run for 24 hours before the monitor is placed back
into operation.
• Modules and PCBs that have been repaired may require more
extensive testing than what is described in this manual.
The pre-assembly testing of printed circuit boards (PCBs) is not

covered in this manual. Disassembly of surface mounted components
on PCBs is not recommended. Tests provided here are only for the
identification of damaged or degraded PCBs.
Field Service Test Any time you open a monitor’s case you must perform electrical
Matrix safety tests before you return the monitor to operation. If you service
the monitor, you should also perform the functional tests.
You should perform additional tests that are specific to modules and
assemblies when you service, adjust, calibrate, or disassemble
assemblies. See the following table.
Withstanding Voltage (Hipot)

Field Service Testing
Gas Flow/CO2 Verification

CO2 Absorber Verification
NIBP Module Calibration

Temperature Verification
SpO2 Performance Test

Communication Testing
Ground Continuity Test
Temperature Check
Main Board Testing
Electrical Leakage
Functional Testing
SPO2 Verification
NIBP Verification
ECG Verification
CO2 Calibration
● Required Test
✔ Recommended Test
No Fault (case opened) ✔ ● ✔ ✔ ✔

NIBP Pump ✔ ● ✔ ✔ ✔ ● ●
SPO2 Board ✔ ● ✔ ✔ ● ✔ ●
ECG/Analog Board ✔ ● ✔ ✔ ● ✔ ✔ ● ●
CO2 Absorber ✔ ● ●
CO2 Board ✔ ● ✔ ✔ ● ●
Main Board ✔ ● ✔ ● ● ● ● ✔ ✔ ● ✔ ● ●
Display/Inverter Board ✔ ● ✔ ● ✔
Membrane Key Pad ✔ ● ✔ ● ✔ ✔ ✔ ✔ ✔ ✔
Printer and/or Board ✔ ● ✔ ✔
Power Module ✔ ● ✔ ● ✔ ✔ ✔ ✔ ✔ ✔
Instrument Dropped ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔
Software Download ● ✔ ✔ ✔ ✔ ✔ ●
Annual Safety Test ✔ ● ✔ ✔ ✔ ✔ ✔ ● ✔
Field Calibration Some of the following procedures require specialized equipment that
Procedures could be available only to larger service facilities.
Criticare recommends that NIBP calibration and calibration of the

ECG/Analog Board be performed at CSI authorized service facilities.
NOTE: For testing and calibration of the CO2 module, see

“Appendix A – CO2 Service.”
DOX SpO2 This test requires a SmartSat Pulse Oximetry Analyzer, Model SS-
100A. The SmartSat is a programmable simulator and probe
Performance Testing analyzer. The SmartSat is the recommended device for testing the
DOX SpO2 module. The SmartSat, model SS-100A, is available from
Clinical Dynamics Corp. of Wallingford, CT.
The SmartSat comes standard with Lemo style connections. The Cat.
No. 913A adapter that converts Lemo to DB-9 style SpO2
connections is needed for the 8100E Series. The analyzer also has a
custom port designed for testing DOX™ SpO2 sensors.
Programming the The SmartSat can be used for spot checking SpO2 values using the
SmartSat Analyzer manual settings. The manufacturer recommends using a timed and
programmed sequence to ensure that there is optimal performance.
For older revisions of SmartSat Analyzer that does not have a

program for the Model 8100E monitor, program the SmartSat as
specified below. Verify that the monitor's display value matches the
corresponding value in the test procedure, not the program settings.
AUTO SEQ: MODEL 8100E Oximeter DOX
Step Time Mod Setting Rate
1 18s 5.00 99 40
2 20s 5.00 96 60
3 20s 5.00 89 80
4 20s 5.00 73 100
5 20s 5.00 52 120
6 20s 5.00 42 180
7 20s 5.00 26 300
8 END
Recent versions of the SmartSat Analyzer are pre-loaded with a

different program, but utilize the same test.
Test Procedure 1. Verify the SpO2 module. (For verification, refer to “SpO2
Verification” on page 5-18.)
2. Attach the monitor to the SmartSat.
3. Start the SmartSat programmed sequence: SmartSat Auto
Sequence. Verify that the monitor’s reported SpO2 values are
within the limits specified.
LevelSaturation(%)Limits(%) Heart Rate Limits
1 99 97 - 99 40 bpm 39-41 bpm
2 96 94 - 98 60 bpm 59-61 bpm
3 90 88 - 92 80 bpm 79-81 bpm
4 78 76 - 80 100 bpm 99-101 bpm
5 61 58 - 64 120 bpm 119-121 bpm
6 52 49 - 55 180 bpm 179-181 bpm
7 40 37 - 43 300 bpm 297-303 bpm
4. Even if the monitor fails only one level, rerun the sequence after
30 seconds. Only if the monitor is successful the second time,
do you pass the monitor.
5. If the monitor fails again, contact the CSI service department.
SpO2 Board Test Values While the DOX SpO2 Board is in operation, it should conform with the
following test values. The operational current draw of the board
should be less than 50 ma. Use TP4 as ground for each
measurement.
Test Point Signal Value
TP3 -5A -5V (±0.05V)
C9(+) +10 +10V (±0.20V)
TP2 +5D 5V (±0.05V)
VR1 (4) -2.5VREF -2.5V (±0.03V)
1. If the any of these values fail to test correctly, isolate the
problem to either the SpO2 Board or the power supply circuits.
2. Remove the SpO2 Board from the monitor.
3. Test the equivalent signals on the ECG/Analog Board circuits,
-5A, +10, +5D, -2.5VREF. See “Assembly Tests” on page 7-9.
4. If the values return to normal with the SpO2 Board removed,
replace the SpO2 Board.
NOTE: The ECG/Analog Board provides power to the SpO2 Board.
The DOX SpO2 Board can be replaced as a serviceable component.

The downloadable software settings associated with the SpO2
module are stored on the ECG/Analog Board. No calibration or SpO2
Board preparation is required.
NIBP Calibration Equipment Required:

• CAT #1320 kit, which includes: NIBP Service Program
(pn 97082A003, Rev. 2)
• PC computer configured for use with CSI Service Software
• 8100 serial download cable, CAT #1320 (pn 90840A004)
• 700cc dummy cuff
• ESD protected workbench
• Digital reference manometer
• Dynatech Nevada NIBP Analyzer
Installing the PC Service The NIBP Service Program is provided on a self-installing CD ROM
Program disk (pn 97082A003, Rev. 2). If the CD ROM does not run
automatically you may need to click on the CD ROM icon.
Run the auto-installation disk. The program NIBPSvc.exe will be

loaded into the Program Files directory. The new folders CSI\Tools
will be created. A launch icon will also be placed on the desktop of
the computer.
Configuring the Ports The Service Program is designed to operate using a serial COM1,
COM3 or COM4 port. If your computer uses USB ports instead of a
serial port an adapter will be required. The following adapters are
recommended:
• IOmega USB to Serial/PDA Converter Cable (GUC232A)
• Keyspan USB Serial Adapter (USA-19HS)
If COM1, COM3 or COM 4 is not available as a free port, the ports

will need to be reconfigured in the computer’s device manager. Go to
Control Panel\System\Hardware and select Device Manager. Select
Ports and reassign the alternate port or the USB to Serial Adapter to
COM1, COM3 or COM 4. For laptops using a USB adapter, select
COM4 or an alternate COM port as necessary.
Calibration 1. Connect a serial download cable from the PC serial port to

“COM2” (J10 on the Main Board). Set the DIN download cable
to NIBP/USER.
COM2
2. Open the service tool on the computer. Select Start > Programs
> CSI NIBP Service > NIBPSvc. Close the disclaimer dialogue
box.
3. Select COM1 for the port and select 8100 Integrated NIBP for
the model. Click on OK.
4. Click on Connection and select Open in Service Mode.
5. Press the nGenuity 8100E monitor ON/OFF key to start the
monitor.
6. Connect a 700cc dummy cuff and manometer to the NIBP fitting
on the unit.
7. Click on the Calibrate button to calibrate the NIBP module.
Figure 6-5: Select Calibrate

8. A box prompting you to attach the digital manometer and
dummy cuff will appear. Verify that the pressure at the cuff is
“0mmHg” ±2mmHg. Click Next.
Figure 6-6: Verify Cuff Pressure
9. Verify that the pressure at the cuff is “0mmHg” ±2mmHg. If the

pressure is not ±2mmHg of zero, the main board must be
replaced. Click Next.
Figure 6-7: Verify Cuff Pressure

10.Check the cuff pressure as indicated on the service screen of
the computer with the pressure indicated on the digital
manometer. The cuff pressure should be within ±0.5 mmHg of
each other. Use the up and down arrows to adjust the gain unit
until the pressures match each other. Click Finish.
Figure 6-8: Finish Calibration

11.A window will appear on the screen indicating that data is being
stored.
Figure 6-9: Storing Data
12.A Positive Confirmation message will appear. Click Done.
Figure 6-10: Positive Confirmation Message
NOTE: If a confirmation fails, power cycle the monitor and

recalibrate.
If the zero base point is out of range, manually set the NIBP
module.
NIBP Performance 1. Restart the service program on the PC. Select Start > Programs
> CSI NIBP Service > NIBPSvc. Close the disclaimer dialogue
box.
2. Turn the monitor’s power on again and establish a new
communications link between the monitor and the PC service
program.
3. To perform the service test for speed, click on the Speed button,
then click on Start. When the unit passes the speed test, press
Done.
4. To perform the service test for leakage, click on the Leak button,
then click on Start. When the unit passes the leakage test, press
Done.
5. To perform the service test for inflation safety, click on the Safety
button, then click on Start. When the unit passes the safety test,
press Done.
6. Turn the monitor off. Click on Abort if an error message appears
on the computer once the monitor is off.
7. Exit the service program on the computer. Remove the
download cable. Click No to exit the program; click Yes to save
the data to a user-specified location.
Temperature 1. Connect the temperature simulator (TP400) to the TEMP

Input Check connector.
2. Verify the Temperature on the display is within ±0.1 C for
temperature simulator settings of 20, 25, 30, 35, 36, 37, 38, 39,
40, and 45C.
3. Disconnect the Temperature simulator from the TEMP
CONNECTOR and verify that the Temperature on the display is
"---. -". Verify TEMP INVALID appears on the display.
4. Repeat steps 1-3 for temperature simulator (TP700).
5. Switch off the power. Disconnect all cables.
Monitor Fault Testing The following procedures are used to determine whether boards and
assemblies are damaged. New boards and mechanical assemblies
should be tested as part of any replacement repair.
Board level tests require opening the monitor housing which can void
your product warranty.
Always follow ESD precautions when performing these procedures.
! DANGER !
• High Voltage! Board testing requires working with dangerous
voltages. The rear assembly, that contains the power supply
module, should only be serviced by experience electrical
technicians.
Power Supply Board Test 1. Remove the batteries from the monitor.
2. Open the case.
3. Follow the disassembly procedures (refer to “Disassembly” in
Section 7 in this manual) to expose the power module. Do not
remove the power module.
4. Disconnect the DC power cable at PS2 of the Main Board.
Leave the other end attached to the Power Supply Board.
5. Using a controlled AC source, apply 115 VAC at 60 Hz to the AC
receptacle. The source should be able to supply a minimum of 3
amps. (Use a power cable that has suitable connections to the
AC source.)
6. Measure the DC power cable end. The power module should
supply 15.3 VDC (±0.1V).
7. Proceed to the next step if the voltage is within specification. If it
is a new board under test, it might not be calibrated. The trim
potentiometer on calibrated boards should be varnished or
otherwise sealed.
8. Reassemble the monitor.
Main Board Testing Test the following conditions without batteries in the monitor.
1. Connect a 15.3VDC 3A power supply to connector PS2 on the
Main Board.
2. Insert an ammeter inline at PS1 on the Main Board.
3. Verify the quiescent current (the power is applied, but the power
control is in the OFF state) is less than 1ma. This quiescent
current decreases to less than 1ma in a very short period of
time. This must be done at the Battery connector. Remove the
ammeter.
4. Connect a speaker to J20 on the Main Board.
5. Connect a membrane switch to J7 on the Main Board.
6. Attach a menu knob to the main board at J8 on the Main Board.
7. Verify that the monitor turns on after pressing the ON/OFF key,
and that the following voltages are present:
Test Point Signal Value
TP21 +PWRUNSW +15.3V (±0.5VDC)
TP4 +5D +5.0V (±0.1VDC)
TP18 +5P +5.0V (±0.1VDC)
TP1 +3.3D +3.3V (±0.05VDC)
TP17 +8V +8.0V (±0.25VDC)
TP7 -5A -5.0V (±0.25VDC)
T13 +6.8 +6.8V (±0.32VDC)
TP9 +5A +5.0V (±0.3VDC)
TP14 +5VREF +5.0V (±0.025VDC)
TP3 +5B +5.0V (±0.25VDC)
Section 7 — Disassembly
Before You Begin
Tools Needed The following tools are needed to perform these procedures:
• #0 phillips screwdriver
• 3/16 flat blade screwdriver
• 11mm deep dish socket and wrench
Before You Begin 1. Turn the monitor off.

2. Disconnect the AC (Mains) power cord and remove the battery.
! WARNING !
• The procedures presented in this section are intended to be
implemented by qualified biomedical engineering or field service
personnel for PCB assembly replacement.
• The procedures presented in this section are not intended to be
used for component-level trouble shooting and repair of the PCB
assemblies. Only CSI service personnel are authorized to
perform component-level repair.
• Possible safety hazard. Read the battery safety information
provided in “Safety” on page 1-16
! CAUTION !
• Opening a monitor and breaking the quality seal can void your
manufacturer warranty! Before breaking the seal on a CSI
monitor, contact the CSI service department.
The repair procedures for the monitor are included here for the
determination of damaged or unusable assemblies. CSI does not
recommend attempting the field repair of the circuit boards.
Service Safety
! DANGER !
• The monitor contains an internal AC power supply that contains
potentially lethal voltages.
• High Voltage! If the power supply is defective, replace the entire
Power Supply assembly.
Electrostatic Discharge The procedures in this section require handling of electrostatic

Protection sensitive components. Microprocessors and other electronic
components can be permanently damaged by attempting repairs at
an unprotected workbench.
Use all electrostatic discharge (ESD) protection as described!

• Perform the disassembly procedure on an antistatic mat that is
grounded. Check the ground cable to insure that it is connected
to a good earth ground.
• Use a grounded soldering iron.
• Wear a wrist-grounding strap.
• Connect the wrist strap and mat through a resistor (1 megohm
typical) to the same ground source.
• Test the wrist-ground straps on a daily basis.
• Temporarily store components in metal or antistatic containers.
Do not store components in plastic dishes. Store circuit boards
in sealed antistatic bags or cover them in antistatic boxes. Do
not store electronic boards directly in cardboard boxes.
Disconnecting and
Replacing the Battery
Remove the Battery 1. Follow all ESD procedures as stated in “Electrostatic Discharge
Protection” on page 7-2.
2. Remove the two (2) screws (PHMS 4-40 x .500 SEMS;
pn 40995B003) from the battery door.
3. Remove the battery door (pn 45182B001) from the rear monitor
enclosure (pn 45179B001).
4. Unscrew battery bracket (pn 42634B002).
5. Label and remove the battery cables from the battery.
Reconnect or Replace 1. Connect the battery cable to the battery:

the Battery • Negative lead (black) to the negative (--) terminal of the
battery
• Positive lead (red) to the positive (+) lead of the battery.
2. Replace battery bracket.
• Wires must not route between battery and bracket.
3. Place the battery door (pn 45182B001) onto the rear enclosure
(pn 45179B001).
4. Insert the two (2) screws (PHMS 4-40 x .500 SEMS;
pn 40995B003) into the battery door and secure.
Printer Repair
Removing Printer 1. Follow all ESD procedures as stated in “Electrostatic Discharge

Assembly Protection” on page 7-2.
2. Remove the battery following the instructions in “Remove the
Battery” on page 7-2.
3. Remove the two (2) screws (PHMS 4-40 x 0.312 SEMS;
pn 40995B001) holding the printer assembly (pn 92804A001) to
the monitor.
4. Label and remove the ribbon cable from the printer module.
5. Remove the module from the main monitor assembly.
Replacing Printer 1. Remove the three (3) screws (pn 40995B005) holding the
Components Printer PCB to the assembly.
2. Disconnect Ribbon Cables J2 and J3.
3. Remove the Printer PCB (pn 91341A003) and set on an
ESD-safe mat. If only the Printer PCB needs to be replaced, go
to step #4.
4. If the print head needs to be replaced:
a. Remove the three (3) screws (pn 41458B001) and the two (2)
brackets (pn 45188B001 and pn 45189B001) holding the
print head in place.
b. Remove the print head (pn 84005B001).
c. Place the new print head into the printer assembly.
d. Reattach Ribbon Cables J2 and J3.
e. Reattach the brackets with the three (3) screws removed
earlier.
5. Place Printer PCB in the assembly and fasten with the three (3)
screws removed earlier.
Reattach the Printer 1. Position the printer module assembly (pn 92804A001) over the
Assembly main monitor assembly.
2. Connect the ribbon cable to the printer module and insert the
module into the main monitor assembly with etch facing PCB.
3. Insert the two (2) screws (PHMS 4-40 x 0.312 SEMS;
pn 40995B001) and secure.
Front Main Chassis

Repair
Disassembly 1. Remove and retain encoder knob from front unit by rotating and
prying the knob off.
2. Remove and retain four (4) nylon screws (pn 42654B002) and
clear plastic insulator (pn 40083B002) from bottom of unit.
3. Remove and retain two (2) phillips flat head screws from bottom
of unit.
4. Remove and retain two (2) phillips flat head screws from rear of
unit near power entry module.
5. Remove and retain two (2) phillips pan head screws and battery
cover from rear of unit battery cover.
6. Remove and retain two (2) phillips pan head screws and either
printer or printer cover from rear of unit.
7. Disconnect printer cable from printer.
8. Remove and retain six (6) phillips head screws from around
edge of unit accessible from rear of unit.
9. Remove quality sticker from the unit.
PCB Replacement SPO2 PCB

To replace the SpO2 PCB assembly (pn 91339A001):
1. Label and disconnect the connectors at P1 and J1 on the SpO2
PCB.
2. Remove the four (4) screws (PHMS 4-40 X 0.500;
pn 40995B003) holding the SpO2 PCB to the chassis assembly.
3. Remove the SpO2 PCB from the mounting plate
(pn 42636B001).
4. Position the new SpO2 PCB over the bracket and connect it to
the SpO2-to-analog cable at P1.
5. Reattach the SpO2 cable to the SpO2 PCB at J1.
6. Place the SpO2 PCB on the SpO2 mount plate.
7. Secure the SpO2 PCB to the mount plate with the four (4)
screws removed earlier.
SHIELDED ANALOG PCB

To replace the Shielded Analog PCB (pn 91353A003):
1. Remove the SpO2 PCB assembly as described in “SPO2 PCB”
on page 7-4.
2. Label and disconnect all connectors. Remove four (4) screws
from the corners of the metal plate which the SpO2 Board is
mounted on. Remove the plate.
3. Remove the four (4) spacers (pn 40909B002) that hold the
shielded analog PCB assembly.
4. Disconnect cables from P1 (ECG Cable) and P5 (Ribbon to
SpO2 Board).
5. Remove the Shielded Analog PCB.
• Be certain when installing the Shielded Analog PCB that P4
is fully seated to the main PCB.
• If not seated properly, the unit will display a CONM H/W error
shortly after Power Up.
MAIN PCB
To replace the Main PCB (pn 91340A004):
1. Remove the four (4) screws (PHMS 4-40 X 0.312 SEMS;
pn 40995B001) that hold the chassis to the front enclosure.
Remove the monitor chassis assembly (pn 92803A001) from the
front enclosure.
2. Label and disconnect all connectors from rear Main PCB.
3. Remove the two (2) screws (PHMS 6-32 x 0.500;
pn 40496B004) and standoffs (F/F 6/32 X 0.625 HEX;
pn 42639B001) from the upper section of the main frame and
the upper section of the Main PCB. Retain the screws and
standoffs for reassembly.
4. Remove the four (4) screws (PHMS 6-32 X 0.250;
pn 40496B002) and the four (4) standoffs (F/F 6/32 X 0.625
HEX; pn 42639B001) from the middle and lower sections of the
main frame and the Main PCB. Retain the screws and standoffs
for reassembly.
5. Remove the Main PCB shield (pn 45192B001) from the main
frame (pn 42635B001).
6. Label and disconnect all connectors from front (Display) of main
PCB.
7. Remove the Main PCB from the shield.
Display Assembly
Display Removal 1. Follow all ESD procedures as stated in “Electrostatic Discharge”

in this section.
Battery” described in this section.
3. Remove the front main chassis as described previously in this
section.
pn 40995B001) that hold the chassis to the front enclosure.
Remove the monitor chassis assembly (pn 92803A001) from the
front enclosure.
5. Remove the four (4) screws (pn 40995B006) that hold the
display to the assembly. Tilt display forward and disconnect all
connectors.
6. Remove the Display assembly from the front chassis.
Membrane Replacement 1. Remove the rotary encoder shaft using 11mm wrench.
2. Carefully press the membrane switch from the chassis. Retain
silicone tubing from membrane studs.
3. Position the membrane switch (pn 45177B001) over the display
chassis (pn 42637B001). Align the four (4) threaded studs on
the membrane switch with the four (4) holes on the display
chassis. Push on the membrane switch and place silicone
tubing onto the four (4) threaded studs.
4. Slide the encoder shoulder washer (pn 42640B001) onto the
rotary encoder (pn 42140B001). Insert the rotary encoder
through the rear of the display chassis so that it protrudes
through the membrane switch.
5. Slide the encoder flat washer (pn 42641B001) onto the rotary
encoder.
6. Place and secure the lock washer and the nut, which is part of
the rotary encoder onto the encoder.
7. Reassemble the monitor.
Display Installation 1. Attach the four (4) pieces that make up the foam gasket
(pn 43614B001) to the display (pn 81520B001).
2. Align the new display over the stand offs of the display chassis.
Secure the new display with four (4) screws.
Bottom Chassis Repair
Disassembly 1. Follow all ESD procedures as stated in ”Electrostatic Discharge

Protection” in this section.
Battery” in this section.
3. Remove the two (2) screws (PHMS 6-32 X 0.375 SEMS
pn 40180B002) from the rear enclosure (pn 45179B001). Refer
to “Front Chassis Disassembly” earlier in this section.
4. Remove the rear enclosure (pn 45179B001) from the front
enclosure assembly (pn 45178B001).
Speaker Replacement 1. Label and disconnect the speaker wire from J20 on the Main
PCB.
2. Remove the speaker assembly (pn 95257A002) and the
speaker mounting plate (pn 42633B001) from the chassis
bottom.
3. Position and place the speaker assembly over the speaker
insulator.
4. Position and place speaker mounting plates (pn 42633B001)
onto chassis speaker studs.
5. Secure speaker with 6-32 keps nuts (pn 40284B002).
6. Attach the speaker wire to J20 on the Main PCB.
NIBP Chassis 1. Label and remove the hoses from the NIBP fitting and Main
Replacement PCB. Disconnect cable from Main PCB (P2).
pn 40995B005) holding the NIBP chassis to the bottom chassis.
3. Remove the NIBP chassis.
4. Position and place the new NIBP chassis assembly
(pn 92797A001) onto the four (4) stand-offs of the riveted
bottom chassis assembly (pn 92798A001).
5. Secure the NIBP chassis assembly with four (4) screws
removed earlier.
6. Reattach connector P2 on the Main PCB and hoses on Main
PCB and NIBP fitting.
Power Supply Replacement 1. Label and disconnect the power supply cable from PS2 on the
Main PCB.
2. Disconnect cable CN1 from power supply.
3. Disconnect groundwire from JP1 and Power Supply.
4. Remove the two (2) screws (PHMS 6-32X0.25 SEMS;

pn 40496B002) from the bottom of the chassis that hold the
power supply bracket in place. Disconnect cable from J5.
5. Remove the existing power supply from the chassis. Connect
cable to J5 on new Power Supply.
6. Position and place the new power supply onto the riveted
bottom chassis assembly (pn 92798A001).
7. Insert the two (2) screws removed earlier through the bottom of
the chassis and into the power supply bracket. Secure the
assembly with the screws.
8. Attach the power supply cable to J20 on the Main PCB.
9. Attach ground wire to JP1 on Power Supply.
10.Attach power cable to CN1 on Power Supply.
Testing Perform the annual safety tests and the electrical safety tests any
time the monitor is opened for repair. These tests are found in
“Preventative Maintenance” in Section 5.
Assembly Tests
Field Service Assembly Testing
Unit Serial Number __________ Main Software Revision __________
Pass Fail
Plug an AC cord into the unit.
The green AC light should be on. _____ _____
Hit the Power key.
The display should show CSI with current revision of software. _____ _____
Check for proper operation of pump by hitting the "NIBP" key.
To insure the membrane buttons are operable, hit the following keys
in sequence and listen for the beep:
FREEZE _____ _____

NIBP CYCLE/STAT _____ _____
NIBP _____ _____
PRINT _____ _____
SILENCE _____ _____
DEFAULT _____ _____
TREND _____ _____
STANDBY _____ _____
Rotate the Encoder knob and verify the cursor moves. _____ _____
Press the encoder and verify a menu is selected. _____ _____
Press the encoder again to exit. _____ _____
List of replaced or repaired modules:

Description Serial Number
__________________________________________ ____________
__________________________________________ ____________
__________________________________________ ____________
__________________________________________ ____________
__________________________________________ ____________
__________________________________________ ____________
Certification of Proper Assembly

Name _____________________________________ Date ________
Assembly Technician
Name _____________________________________ Date ________
This checklist may be copied.
Section 8 — Troubleshooting
This section lists the possible causes of monitor problems. Use this
table and the schematics in “Drawings and Schematics” in Section 9
to identify and locate components that malfunction.
Symptom Problem Solution
Unit won’t power up (On/ • Battery is not connected Fully seat battery connection
Off LED is dark) • Battery is discharged Connect AC power cord
• AC power cord is not Connect AC power cord to monitor
securely connected to
monitor
• AC outlet off or unpowered Connect power cord to a live outlet
• Fuses are blown (Located Replace AC fuses (pn 80131B002)
below AC connection
• Main Board is disconnected Reconnect DC power cable at PS2
on Main Board
• Bad membrane Replace the keypad membrane
• Main Board fuse blown Replace F2 on Main Board for
battery or F4 for Power Source
Cannot activate hardkey • Membrane panel is not Reconnect ribbon cable to J7 on
function or turn on securely connected Main Board
monitor with AC power • Keypad membrane is bad Replace keypad membrane panel
(On/Off LED is green) • Inverter is bad Replace the inverter
• Main board is bad Contact CSI Service Department
Display is blank or not • Video screen cables to Main Reconnect data and inverter cables
readable Board are disconnected or to connectors on Main Board
loose (J2, J3, J4, and/or J5)
• Inverter malfunction Make sure all Inverter connections
are secure.
• Inverter is bad Replace the inverter
NIBP air leak • Defective cuff Replace Cuff
• Defective hose Replace Hose
• Pneumatic tube leaks Re-seat tube or replace pneumatics
• Defective valve Contact CSI Service Department
• Defective main board Contact CSI Service Department
NIBP not functioning • Pump disconnected Reconnect pump to P2 on Main
Board
• Pump motor failure Contact CSI Service Department
• Main Board pump driver bad Contact CSI Service Department
• NIBP calibration error Contact CSI Service Department
Symptom Problem Solution
SpO2 not functioning • SpO2 Board disconnected Reconnect to P5 on ECG/Analog

Board and check the connection at
P1 on SpO2 Board
• Defective SpO2 Cable Replace cable
• ECG S1 switch set wrong Adjust switches to correct module
(1-4 OFF for DOX SpO2)
• Main board malfunction Contact CSI Service Department
ECG noise or • Poor electrode placement Reposition/replace electrodes
intermittent function • Bad/wrong ECG Cable Replace ECG cable
• Line Frequency/Filter wrong Check ECG settings
• ECG connection worn Replace ECG port
• Cable to ECG/Analog Board Replace cable assembly at P1 on
bad ECG/Analog Board
• Defective analog PCB Replace Analog board
SpO2 is “noisy” • Sensor may be bad. Replace the sensor.
• Receptacle may be Replace receptacle.
damaged.
• The connection between Reseat the connection.
Main Board J12 and ECG/
Analog Board P4 is loose or
disconnected. (Can be
verified by presence of
CONM H/W error.)
• Main Board or ECG/Analog Replace Board(s)
Board may be bad.
No sound from speaker • Volume turned down Set volume higher in Configuration
(CONFIG) window.
• Main Board connection is Reconnect J20 on Main Board
disconnected or loose
• Speaker wire broken at Check speaker wires for breaks or
speaker terminals bad crimp pins
Speaker scratchy or • Metal debris on speaker Remove debris from speaker drum
unclear sound • Bad speaker Replace speaker
COM 1 serial interface • Set to internal printer Reset monitor to external printer
doesn’t work • Incorrect or bad cable Replace with correct serial cable
• Setting mismatch Reset baud rate and other settings
• Connector is bad Replace the Main Board
No ECG trace displays • ECG Cable may be bad. Replace with known good cable.
• The connection between Reseat the connection.
Main Board J12 and ECG/
Analog Board P4 is loose or
disconnected. (Can be
verified by presence of
CONM H/W error.)
• Main Board or ECG/Analog Replace Board(s)
Board may be bad.
Troubleshooting and Before attempting to repair a damaged monitor the technician must
Repair fully understand the functions of the monitor. The service technician
should have read and understood all the previous sections of this
manual.
You must fully repair, calibrate, and test all damaged monitors before
you use them on patients. The monitor must meet the original
operating specifications before you use it on a patient.
Always follow ESD precautions when performing any of the

procedures discussed in this section.
ComfortCuff NIBP The NIBP module consists of a pneumatic pump assembly

Module (pn 95576A003) and control circuitry located on the Main Board
(pn 91340A004).
The pneumatics assembly is mounted on the back side of the metal

chassis plate. A large diameter tube (pn 41602B001) connects to the
Quick-Connect hardware fixture and the transducer on the Main
Board. The transducer port faces out the back side of the Main Board
through a hole.
The remaining pneumatics links connect the two control valves

(pn 95596A004), the pump (pn 95576A005), and the check valve
(pn 41579B003). As the tubing ages it may lose its seal. Old tubing
can be re-seated or replaced as necessary.
When any major pneumatic component such as a pump or valve is

replaced, the NIBP module must be re-calibrated as in “NIBP
Calibration” in section 6 of this manual. The manufacturer
recommends that the monitor be returned to a CSI authorized service
facility if pump replacement is required.
The transducer SENS1 and the zero point calibration pot R92 are not
field serviceable components. Improper replacement can result in
permanent damage to the Main Board.
ECG/Impedance The ECG circuitry is located on the ECG/Analog Board assembly

Respiration Module (pn 91353A003) that is attached to the metal chassis behind the main
board.
The ECG/Analog Board fits directly on to the Main Board through a

socketed 10-pin connection on the left side of the board assembly.
There is also a shielded cable assembly that extends from the top of
the board to the external ECG port. Check each of these connection
points if the monitor fails to produce an accurate ECG waveform.
The ECG/Analog Board has a foil shield to reduce noise from other
portions of the monitor. Noise can be introduced by worn cable
assemblies and degraded power supplies. Test the analog ECG
waveform signal and the input power where they enter the ECG/
Analog Board for interference noise.
There is a replacable 2-amp fuse (pn 80004B003) at location F1 on

the ECG/Analog Board. The fuse provides protection in the power
circuit leading from the P4 connection to the Main Board. Surface
mount components on the ECG/Analog Board are not recommended
for field repair and replacement.
You can replace the ECG/Analog Board assembly as a serviceable

component. Replacement ECG/Analog Board assemblies,
(pn 91353A003) are pre-tested, software loaded, and calibrated. The
monitor requires complete safety testing after reassembly.
NOTE: Always check line frequency, filter settings and the ECG lead
cables as part of any ECG trouble shooting. Always use the
recommended simulators for performance testing.
Board Settings and Module There are three pots under the shielding at locations R112, R110,
Software and R108. They are the baseline adjustments for ECG I, EGG II, and
ECG V respectively. These are factory set; you should not adjust
them. Set the S1 switches (off) in the open position to allow
communication with the DOX module. See “ECG Verification” in
Section 5.
The ECG/Analog Board contains its own on-board software that is

factory loaded. The program is stored in non-volatile memory on the
ECG/Analog Board. Repair or improper handling of the ECG/Analog
Board can corrupt this software.
Respiration The respiration circuit is located on the ECG/Analog Board. There is

no separate calibration or testing for the impedance respiration.
Temperature The temperature module is located on the ECG/Analog Board. There

are no on-board settings or service calibrations. The temperature
module is auto-calibrating upon start-up.
DOX SpO2 Module The DOX SpO2 module consists of a separate board that is attached
above the ECG/Analog Board. There is a communication connection
for a ribbon cable (pn 90866A001) at the bottom edge of the ECG/
Analog Board. The ribbon cable extends to the SpO2 Board. There is
also a short cable to the ECG/Analog Board (pn 90866A002).
The plethysmograph input signal enters the SpO2 Board through a

shielded cable that runs between the boards and metal chassis to the
opposite side of the monitor.
The DOX SpO2 module is composed of digital components that are

not effected by noise. There is also no signal degradation or loss of
calibration due to analog components. Interference or noisy signal
can be due to a worn cable assembly or DB-9 connector. Replace the
connector and cable assembly if necessary.
Always check the sensor when intermittent problems are reported.

Stretched or otherwise damaged sensor cables must be replaced.
NOTE: The line frequency setting of the monitor must be set correctly
for optimal SpO2 monitoring.
Main Board The Main Board (pn 91340A004) contains the primary processors,
storage memory, NIBP circuitry, communication interfaces, audio
driver, vital signs module connections, power regulation, battery
charge circuits, video generation, and keypad inputs (User I/O).
The Main Board has an adjustable pot R92 that you set during NIBP
calibration. There are two CPUs on the Main Board that you must
program from a CSI Service Download Station. The programmable
settings remain in non-volatile memory. Repair or improper handling
of the Main Board can corrupt this software.
There is one (1) replacable 3-amp fuse (pn 82004B001) for the
battery input at PS1. There is one (1) replaceable 4A fuse
(pn 82004B010) for the power supply module at PS2 (F4 protects the
supply output).
If you replace the Main Board you are required to cal-check the NIBP
module. NIBP pneumatics assemblies and Main Boards may not be
changed unless re-calibrated.
Except for fuses, the Main Board is not a field-repairable component.

Replacement Main Boards are pre-tested, programmed, and
calibrated.
Power Module The power module (pn 95710A002) consists of the battery
compartment bulkhead and chassis, the fan, cable assemblies, and
the Power Supply Board. The Power Supply Board (AC to DC
converter) is not a field-repairable component. If the board is
damaged or fails test replace the entire assembly.
! DANGER !
• High Voltage! Repairing and testing the power supply requires
working with dangerous voltages. The power supply module
should only be serviced by experienced electrical repair
technicians.
Fuse Replacement The main fuses (pn 82013B002) for the power module is located in an
external compartment above the AC power cord connection. Replace
only with:
• 1A/110/230 volt Time-Lag fuses (pn82013B002).
Check the monitor ID label to determine which voltage the unit uses.
You do not have to open the monitor case to change the main power
fuses. See “Fuse Removal/Replacement” in Section 5.
! WARNING !
• Shock hazard! Substitution of fuses or jumping the fuse

contacts can endanger the patient and damage the monitor.
AC Power Components The power entry module (pn 80243B002), when replaced, must
remain electrically isolated between the chassis and power entry
module ground. The AC power entry module requires a fuse drawer
(pn80130B001).
Replace broken, cracked, or loose AC receptacles. Replace the

receptacle if the external pins are bent or broken. Do not attempt to
remove or modify the ground pin!
Check the cables and chokes for heat damage before power module
replacement. Remove the assembly from the housing and inspect the
back side of the board for scorching or damaged solder connections.
Replace the entire assembly if there are any signs of high current
damage.
Section 9 — Drawings and Schematics
List of Drawings Title Drawing Number
Assembly BOMs Final Assembly 8100E (without printer) 93979A001

and Drawings Final Assembly 8100EP (with printer) 93979A002
Final Assembly 8100E1 (w/ CO2, no printer) 93979A011
Final Assembly 8100EP1 (w/ CO2 and printer) 93979A012
Main Monitor Assembly 92800A001
Main Monitor with CO2 Assembly 92800A002
Chassis Assemblies 92803A001
Bottom Chassis Assembly 92799A001
Power Supply with Brackets 95710A003
Main Chassis Assembly 92801A001
NIBP Chassis Assembly 92797A001
CO2 Internal Module Assembly 92811A001
CO2 External Module Assembly 92811A002
Display Chassis Assembly 92802A001
Assembly Patient Connectors 95767A001
Shielded Analog Board Assembly 91353A003
Printer 92804A001
PCB Drawings Title Drawing Number

and Schematics Main Board 8100E/8100EP 91340A005
Main Board 8100E/8100EP Schematic 91340S005
Analog Board 8100 91342A003
Analog Board 8100 Schematic 91342S003
SpO2 Board 91339A001
SpO2 Board Schematic 91339S001
Final Assembly
8100E (Without Printer) 93979A001 FINAL ASSEMBLY 8100E

Item # CSI Part # Description
01 92800A001 AY MAIN MONITOR
02 45183B001 COVER NO PRINTER
03 40995B001 P.H.M.S. 4-40X.312 SEMS
05 95773A001 LABEL SET 8100E/EP ENGLISH
06 41891B002 DB9 COVER PLATE
07 41891B003 PLATE COVER MINI-DIN
08 40995B005 P.H.M.S. 4-40X.25 SEMS
8100EP (With Printer) 93979A002 FINAL ASSEMBLY 8100EP

01 92800A001 AY MAIN MONITOR
02 92804A001 AY PRINTER MODULE
03 40995B001 P.H.M.S. 4-40X.312 SEMS
04 40065B002 PAPER THERMAL 2.283 WIDE
08 40995B005 P.H.M.S. 4-40X.25 SEMS
8100E1 (With CO2) 93979A011 FINAL ASSEMBLY 8100E1

01 92800A002 ASSEMBLY MAIN MONITOR
02 45183B001 COVER NO PRINTER
03 40995B001 P.H.M.S. 4-40X.312 SEMS
08 40123B004 P.H.M.S. 4-40X.250 NY WHT
8100EP1 (With CO2 and 93979A012 FINAL ASSEMBLY 8100EP1

Printer
01 92800A002 ASSEMBLY MAIN MONITOR W/CO2
02 92804A001 AY PRINTER MODULE
03 40995B001 P.H.M.S. 4-40X.312 SEMS
04 40065B002 PAPER THERMAL 2.283 WIDE
08 40123B004 P.H.M.S. 4-40X.250 NY WHT
Main Monitor Assembly 92800A001 AY MAIN MONITOR

01 92803A001 AY CHASSIS MONITOR
02 45178B001 ENCLOSURE FRONT
03 92810A001 AY REAR ENCLOSURE 8100EP
04 42127B001 WINDOW FILTER 10.4
05 87285B001 INSERT EXTERNAL CONNECTORS
06 87277B002 FOOT 7/16 OD X 5/32 HIGH
09 45182B001 BATTERY DOOR
10 42141B002 KNOB ROTARY ENCODER CUSTOM
12 42431B011 STANDOFF M-F 6-32 X 1.5
13 45194B001 INSULATOR BOTTOM
14 40995B001 P.H.M.S. 4-40X.312 SEMS
15 40995B003 P.H.M.S. 4-40X.500 SEMS
16 40496B001 P.H.M.S. 6-32X.375 SEMS
17 40180B002 F.H.M.S. 6-32X.375 PL PH
18 40083B002 F.H.M.S. 8-32X.375 PH PL
19 42654B002 P.H.M.S. #8-32 X .375 NYLON
21 40067B001 CABLE TIE 4.0
22 83338B002 DISPLAY FILM
23 42115B001 SCREW FH #4X3/8 HI-LO PH
24 42431B007 STANDOFF M-F 6-32 X 7/8
25 49038B001 TAPE 1 X 1/16 2 SIDED
26 40067B003 CABLE TIE 8
27 40294B001 HOLDER TIE WRAP ADH-BK SM
28 42634B002 BRACKET BATTERY LOCK
29 42643B002 FOAM PAD BATTERY
30 80519B001 BATTERY, SLA 12V, 5AHR
Main Monitor with CO2 92800A002 ASSEMBLY MAIN MONITOR W/CO2

Assembly
01 92803A001 AY CHASSIS MONITOR
02 45178B001 ENCLOSURE FRONT
03 92810C001 AY REAR ENCLOSURE 8100EP
04 42127B001 WINDOW FILTER 10.4
05 87285B001 INSERT EXTERNAL CONNECTORS
06 87277B002 FOOT 7/16 OD X 5/32 HIGH
07 92811A001 CO2 MODULE AY NGENUITY
08 92811A002 CO2 MODULE AY EXTERNAL 8100E/P
09 45182B001 BATTERY DOOR
10 42141B002 KNOB ROTARY ENCODER CUSTOM
12 42431B011 STANDOFF M-F 6-32 X 1.5
13 45194B001 INSULATOR BOTTOM
14 40995B001 P.H.M.S. 4-40X.312 SEMS
15 40995B003 P.H.M.S. 4-40X.500 SEMS
16 40496B001 P.H.M.S. 6-32X.375 SEMS
17 40180B002 F.H.M.S. 6-32X.375 PL PH
18 40083B002 F.H.M.S. 8-32X.375 PH PL
19 42654B002 P.H.M.S. #8-32 X .375 NYLON
21 40067B001 CABLE TIE 4.0
22 83338B002 DISPLAY FILM
23 42115B001 SCREW FH #4X3/8 HI-LO PH
24 42431B007 STANDOFF M-F 6-32 X 7/8
25 42431B009 STANDOFF M-F 6-32 X 1.25
26 40284B002 NUT 6-32 KEPS PL
28 42634B002 BRACKET BATTERY LOCK
30 80519B001 BATTERY, SLA 12V, 5AHR
Chassis Assemblies 92803A001 AY CHASSIS MONITOR

01 92799A001 AY CHASSIS BOTTOM
02 92801A001 AY CHASSIS MAIN
03 92802A001 ASSEMBLY CHASSIS DISPLAY
08 40496B002 P.H.M.S. 6-32X.250 SEMS
09 40132B001 TAPE MICROFOAM ADH-BACKED
Bottom Chassis Assembly 92799A001 AY CHASSIS BOTTOM

01 92798A001 AY CHASSIS BOTTOM RIVETED
02 95710A003 AY POWER SUPPLY WITH BRACKETS
03 92797A001 ASSEMBLY NIBP CHASSIS
04 95257A002 SPEAKER ASSEMBLY
05 90865A003 CBL AY PWR SUPPLY TO MAIN
06 90968A004 CBL AY INLET GROUND
07 95768A001 CABLE AY, BATTERY TO MAIN PCB
08 80243B002 PWR ENTRY MODULE, FILTERED
09 80130B001 PWR RECPT/FUSE DRAWER
10 82013B002 FUSE T TIME LAG 1A L 250V 5X20
12 45193B001 INSULATOR POWER INPUT
13 42633B001 PLATE SPEAKER MOUNTING
14 45187B001 INSULATOR SPEAKER
17 41537B001 FOAM DISK 1.38 DIA .25THK
18 41158B001 TERMINAL EQUIPOTENTIAL
19 40995B005 P.H.M.S. 4-40X.25 SEMS
20 40496B002 P.H.M.S. 6-32X.250 SEMS
21 41297B001 F.H.M.S. 4-40X.375 PL PH
22 40284B001 NUT 4-40 KEPS PL
23 40284B002 NUT 6-32 KEPS PL
24 41164B001 NUT M6 X 1.0 KEPS PL
25 42353B001 SHOULDER WASHER #4
26 42448B001 1/4-20 SS316 SPRNG LOCK
27 40500B003 WASHER FLAT #6 NY .062THK
29 40067B001 CABLE TIE 4.0
30 40067B002 CABLE TIE 5.6
32 42402B002 BATTERY SLIDE 8100EP
Power Supply with Brackets 95710A003 AY POWER SUPPLY WITH BRACKETS

01 86523B001 POWER SUPPLY 60W
02 42368B002 BRACKET RIGHT PS
03 42369B002 BRACKET LEFT PS
05 40995B003 P.H.M.S. 4-40X.500 SEMS
06 40887B002 SPACER NY #6/.250D/.250L
07 41157B001 THRDLOCK ASSURE SURF CUR
08 42501B002 GROMMET STRIP WITH ADHES
09 42499B002 WASHER CUP NYLON #4
Main Chassis Assembly 92801A001 AY CHASSIS MAIN

01 42635B001 FRAME MAIN
02 91340A005 ASSY MAIN PCB 8100E1/EP1
03 91353A003 AY SHIELDED ANALOG BRD
04 91353A002 AY SHIELDED ANALOG BRD
05 42636B001 PLATE SPO2 MOUNT 8100E/EP
06 95767A001 ASSEMBLY PATIENT CONNECTORS
07 90866A002 CABLE SPO2 TO ANALOG
08 45192B001 SHIELD MAIN PCB
09 82569B001 FERRITE BEAD
10 42642B001 SPACER MAIN PCB
11 40496B002 P.H.M.S. 6-32X.250 SEMS
12 40496B005 P.H.M.S. 6-32X.750 SEMS
13 42639B001 STANDOFF F-F #6-32 X .625 HEX
14 40909B002 SPCR HEX 6-32X.625 NY M/F
15 49038B001 TAPE 1 X 1/16 2 SIDED
16 40067B003 CABLE TIE 8
17 42501B002 GROMMET STRIP WITH ADHES
18 40035B001 TAPE ELECTRICAL BLK .75
19 83111B002 8100 PRINTER CBL
20 40995B003 P.H.M.S. 4-40X.500 SEMS
21 41371B001 TAPE INSUL KAPTON 2
NIBP Chassis Assembly 92797A001 ASSEMBLY NIBP CHASSIS

01 95576A005 AY PUMP WITH WIRES
02 95596A004 AY OKEN VALVE WITH CRIMPS
03 95595A001 AY VP NIBP MANIFOLD
04 42629B001 BRACKET NIBP
05 40296B001 TUBING SILC BLU .040X.140
06 42081B002 ORIFICE RESTRICTOR .0125
07 42111B001 SCREW M2-.4X3 PH BINDER
08 41700B001 TUBING POLYU .094IDX.1870
10 42069B001 TUBING 1/4X1/8 POLYU COIL
12 40067B002 CABLE TIE 5.6
13 40067B001 CABLE TIE 4.0
14 41955B001 FOAM TAPE 1.0 X 2.12
15 41579B003 CHECK VALVE
16 80111B001 FERRITE BEAD EMI SHIELD
17 40041B009 TUBING SHRINK .375 CLEAR
18 87151B006 HOUS SOCKET .098 LOCKING
20 41157B001 THRDLOCK ASSURE SURF CUR
CO2 Internal Module 92811A001 CO2 MODULE AY NGENUITY

Assembly
01 91783A001 AY PNEUMATICS CO2
02 91784A001 AY PLATE PNEUMATIC RECEPTACLES
03 91407A001 AY PCB CO2
04 42689B001 CHASSIS CO2 INTERNAL
05 94254A004 AY PUMP W/CONNECTOR 3 WIRE
06 41188C201 CO2 DETECTOR
07 83304B001 GASKET DETECTOR/IR SOURCE
08 40995B005 P.H.M.S. 4-40X.25 SEMS
09 40496B002 P.H.M.S. 6-32X.250 SEMS
10 40496B004 P.H.M.S. 6-32X.500 SEMS
13 42688B001 FITTING ELBOW 1/8-1/16
14 41002B002 TYGON TUBING .063 ID X .125 OD
15 40214B007 TYGON TUBING .125DX.187OD
16 40887B002 SPACER NY #6/.250D/.250L
17 42691B001 WASHER, SHOULDER #6, .40 LONG
18 46597B001 LBL MANIFOLD CONNECTIONS
19 46598B001 LBL PNEUMATICS RECPTACLES
20 90903A002 AY CABLES VALVES CO2
21 40283B002 WASHER FLAT #4 NY .032
23 42694B001 ACCULULATOR, CO2
24 40067B003 CABLE TIE 8
25 90926A002 CABLE AY NIBP TO MAIN BOARD
26 42155B001 FOAM PAD 8100E PUMP
27 42172B002 P.H.M.S. #6-20 X .38” LG SELF TAP
28 40893B001 WASHER FLAT #8 PL
29 41371B001 TAPE INSUL KAPTON 2
CO2 External Module 92811A002 CO2 MODULE AY EXTERNAL 8100E/P

Assembly
01 45205B001 ENCLOSURE EXTERNAL CO2
02 91785A001 AY PLATE PNEUMATIC PLUGS
03 42348C003 MOD MANIFOLD
04 95780A001 AY TRAP DETECT 8100E
05 40297B002 TUBING, SLCN .093IDX.390OD
06 42686B001 SHOULDER SCREW
07 42687B001 CLIP MANIFOLD
08 41458B001 P.H.M.S. 4 X .250 HI/LO
09 40570B004 ABSORBER IBENCH
10 42299B001 RETAINER TRAP DETECT
11 42300B001 MOUNTING BLOCK TRAP DETECT
12 42064B005 F.H.M.S. 4-40X.500 PH PL
13 41002B002 TYGON TUBING .063 ID X .125 OD
14 42692B001 PAD 1.00 X .25
15 42335B001 METRIC PAN HEAD M3X8
Display Chassis Assembly 92802A001 ASSEMBLY CHASSIS DISPLAY

01 42637B001 CHASSIS DISPLAY
02 81520B001 LCD ACTVE TFT 10.4 NEC-59
03 40614B001 DISPLAY CABLE 8100E
04 90859A005 ASY CABLE MAIN BOARD TO INVRTR
05 83265B003 BACKLIGHT INVERTER
06 45177B001 MEMBRANE SWITCH
07 45181B001 BRACKET DISPLAY MOUNT
09 42140B001 ROTARY ENCODER
10 42640B001 WASHER SHIELDED ENCODER
11 42641B001 WASHER FLAT ENCODER
13 43614B001 FOAM GASKET 9.25 x .25 x .060
17 40995B005 P.H.M.S. 4-40X.25 SEMS
18 40995B006 #4-40 PHMS SEMS PHILLIPS
21 42652B001 STANDOFF F-F 2-56 NYLON .5 LNG
Assembly Patient 95767A001 ASSEMBLY PATIENT CONNECTORS

Connectors
01 87284B001 INSERT PATIENT CONNECTORS
02 90860A001 AY CBL 8100 SPO2 TO DB9
03 90872A005 ASSEMBLY CABLE TEMP CONNECTOR
04 42014B001 FITNG, QUICK CON. HH NIBP
06 40284B005 NUT 10-32 KEPS PL
07 41458B001 P.H.M.S. 4 X .250 HI/LO
08 40086B001 WASHER FLAT PL .125X.219
09 90817A005 AY CBL 8100 ECG TO OUT
Shielded Analog 91353A003 AY SHIELDED ANALOG BRD

Board Assembly
01 91342A003 ASSEMBLY ANALOG PCB 8100
02 41785B004 SHLD ANALOG BRD 8100
03 40995B011 P.H.M.S. 4-40 X .438 SEMS
04 40086B001 WASHER FLAT PL .125X.219
05 83358B001 INSULATOR ECG SHIELD
06 83434B001 CIRCUT BRD ECG SHEILD
07 40284B001 NUT 4-40 KEPS PL
08 40431B001 WIRE 18AWG 300V GREEN/YELLOW
09 40884B001 SPACER #4/.250OD/.125L PL
Printer 92804A001 AY PRINTER MODULE

01 45184B001 ENCLOSURE PRINTER
02 45186B001 DOOR PRINTER
03 84005B001 PRINTER SEIKO
04 91341A003 PCB AY SEIKO PRINTER
05 45188B001 BRACKET PRINTER
06 45189B001 BRACKET PRINTER SMALL
07 40418B001 DOWEL PIN .125”D X 2.0”L
08 41458B001 P.H.M.S. 4 X .250 HI/LO
09 40995B005 P.H.M.S. 4-40X.25 SEMS
10 45209B001 INSULATING DOT 1/4 INCH
Appendix A — CO2 Service
Service Windows Monitors with CO2 will have additional items in the Service Mode
window. The additional items are highlighted below.
EXIT
Enter NIBP Service NO

Enter CO2 Service NO
Software Download No action taken
Permanent Alarm Silence Enable
ST / Arrhythmia Keycode ------ Invalid Keycode
Current Software Revisions

Main Display Processor Rev 2.0C
NIBP Processor Rev 6.6D
Vital Signs Processor Rev 6.2A
CO2 Processor Rev 0.3B
Unit Serial Number 111111111

Unit Part Number 93979AXXX
Keycode Base Number 00000000
Figure A-1: Service Mode Window
CO2 Operating Mode User Mode

CO2 Zero Cal Abort CO2 Zero Cal
CO2 Gain Adjustment Turn to Incr/Decr, Press to Save
CO2 Factory Defaults? No Action
N2O compensation OFF
Figure A-2: CO2 Service Window
Criticare Systems, Inc. nGenuity™ 8100E Series Service Manual Page A-1
Theory of Operations
Capnometer Module (CO2) The capnometer contains the circuitry for monitoring the sidestream
CO2 level by actively sampling from the patient’s airway. It contains
provisions for interfacing with galvanic oxygen monitoring option sub-
modules. No electrical connection is made with the patient from the
monitor for capnometry. The CONM module controls the capnometer.
The CO2 Board contains an assembly known as a “bench.” This

bench contains the optics, IR source, detector, sample cell, and
optical filters. The purpose of this bench is to convert CO2 levels in a
gas sample to electrical signals.
The bench assembly utilizes the principle of infrared absorption

spectrometry to measure to the amount of CO2 in patients breath.
Infrared absorption spectrometry is widely used in gas analysis.
Using a phenomenon explained in “Beers Law,” CO2 gas absorbs
certain wavelengths of infrared energy with the amount depending on
the amount of CO2 gas. A detector, outfitted with an infrared
bandpass filter, only allows a certain wavelength of infrared energy
that the CO2 gas absorbs. As the CO2 concentrations in the sampled
air passes through the sample cell, the detector senses the infrared
energy changes and converts them to an electrical signal. This
electrical signal is then amplified and conditioned and sent to a
microprocessor for processing and then sent to a display.
The CO2 Board also uses a reference channel. The purpose of this
reference channel is to “cancel” the effects of IR source changes,
sample cell contamination, temperature, etc. The only difference from
the CO2 channel is that the detector is outfitted with an optical filter
that is tuned to a band in the infrared spectrum that is transparent to
CO2 and other gases typically found in the medical industry. The
signal from the reference channel is processed similarly to that of the
CO2 measurement channel.
The CO2 and reference detectors work by an effect known as

“pyroelectric.” Pyroelectric effect works by changing energy levels,
either increasing or decreasing, that are imposed on a sensing
element. The detector is outfitted with an optical bandpass filter that
passes only a narrow band of a determined wavelength of infrared
energy. The infrared source is modulated at 15 hertz (Hz) to provide
varying energy for the detector and amplifier circuits.
Correction for temperature and pressure effects on the CO2 sample is

implemented to maintain accuracy over a wide temperature and
atmospheric pressure range.
Page A-2 nGenuity™ 8100E Series Service Manual Criticare Systems, Inc.
Block Diagram The following block diagram aids in tracing the connections for the
CO2 module.
SpO2
CO2 Cable
Board
Pump Motor J1
J1
SpO2 Board
Connection
External
Module
CRT
Con
P1
Jumper Temp
P5
P3
Probe
ECG/Analog
(DB-15)
J15
J14
J16
JP1
J17
Board
(Speaker Jack)
Thermistor
J18
Power Nurse
J13
Call Con
Module
J19
Fan
Assembly
P4
J12
P1
P2
J20
Power Speaker
(BNC)
ECG Out
J11
Board
PS2
J2
(DIN 8)
J10 COM2
J1
TP8
Battery
TP6
Main Board
PS1
Connector
Download
ECG
Board
DB9
COM1
TP4
J9
TP2
Solder Side
Pump
P2
(NIBP)
L/N
GND
J1
JTAG Rotary
P1
J8
Isolation Board
Con Component Side Encoder

AC Line
L/N/G
J7
Keypad
Printer
CN1
J1
J6
J3
J4
J2
J5
Board
CN2
CN3
Not Used
Active
LED
Motor
Not Used
Not Used
Backlight
Head
Print
Preventative
Maintenance
Maintenance Schedule Perform these maintenance tasks in addition to those listed in the
Maintenance Schedule in Section 5.
EVERY PATIENT
• Change the gas sampling device and sampling line.
EVERY WEEK
• Change the water trap (or as needed).
EVERY 3 MONTHS
• Clean the exterior of the unit (or as needed).
EVERY YEAR
• Verify the CO2 auto-calibration. Calibrate if necessary.
• Check the CO2 absorber. Change if necessary.
• Check the gas flow rate. Adjust if necessary.
CO2 Absorber Verification The granules in the CO2 absorber are normally white, indicating a
good absorber. If the granules remain violet or blue, the absorber is
spent and needs to be replaced.
NOTE: The absorber can change color during use, but should always
return to its original white color when not in use.
Verifying the state of the CO2 absorber requires removing the

external CO2 module from the monitor. See “Check/Replace the CO2
Absorber” located under “Disassembly” later in this appendix for
instructions on removing the external CO2 module from the monitor.
Gas Flow/CO2 Verification TOOLS NEEDED

• Flow Meter
• Vacuum Gauge (0-25 inches of mercury)
• WaterChek™ 2+ Water Trap (CAT 938F-NC)
• Sample Line (CAT 625N)
• Calibration Gas, 10% CO2 with accuracy ±2% (CAT 622)
• Regulator (CAT 623)
• Regulator Bleed Tube (CAT 613B)
! CAUTION !
• Calibration kits contain compressed gas cylinders. Read and
obey all precautions listed on the gas cylinder labels.
• Do not use if the calibration gas cylinder is beyond its
expiration date.
• Check the accuracy of the test gas. The gas must be within the
accuracy stated above to ensure proper verification.
NOTE: Make sure the monitor is not in STAND BY mode before

proceeding with the following procedures.
PREPARATION
1. Insert a water trap (CAT 938F-NC) and sample line (CAT 625)
on the 8100E1 monitor.
2. Turn the 8100E1 monitor on and allow to run for 30 minutes.
FLOW VERIFICATION
1. Connect a flow meter to the end of the sample line and measure
the flow. The flow should be 200 ml/min ±10% (20.0 ml/min).
2. Disconnect the flow meter from the sample line.
OCCLUSION TEST
1. Connect a vacuum gauge to the sample line. There should be
more than 12.5 inches of mercury of vacuum.
2. Verify that CO2: OCCLUSION appears on the monitor and that
the pump turns on.
3. Disconnect the vacuum gauge from the sample line.
EXHAUST TEST
1. Place the flow meter on the Exhaust Port and measure the flow.
The flow must be greater than 250 ml/min.
2. Remove the flow meter.
CO2 VERIFICATION
1. Check that the CO2 measurement is displayed in PERCENT. If
not set in the Parameters menu (PARAMS).
2. Using the regulator (CAT 623) and regulator bleed tube (CAT
613B) connect the 10% CO2 gas canister to the sample line.
3. Turn on the 10% CO2 gas by turning on the knob on the
regulator. Allow the gas to run for 30 seconds. Verify that the
CO2 reading is ±6% [9.4 to 10.6]. Turn off the gas when finished
and disconnect from the sample line.
NOTE: The 6% accuracy is derived from the test tolerance of

4% combined with the 2% accuracy of the gas canister.
Testing Checklist A “Verification Checklist” is at the end of this appendix. This checklist
should be added to the “Functional and Safety Testing Checklist” in
Section 5.
CO2 Calibration
Tools Needed The following equipment is needed to perform this procedure:

• WaterChek™ 2+ Water Trap (CAT 938F-NC)
• Sample Line (CAT 625N)
• Calibration Gas, 10% CO2 with accuracy ±2% (CAT 622)
• Regulator (CAT 623)
• Regulator Bleed Tube (CAT 613B)
• Breath Rate Simulator (CAT 1466)
! CAUTION !
Before You Begin Make sure the CO2 calibration gas cylinders are not depleted or
nearly depleted. The pressure meter should be above zero and you
should not hear a “hissing” sound when in use.
! WARNING !
• Never attach intravenous tubes to gas sample connections

because the gas sampling lines could inadvertently be
connected to intravascular fluid systems, thus allowing air into a
blood vessel.
! CAUTION !

• Do not use if the calibration gas cylinder is beyond its
expiration date.
• Check the accuracy of the test gas. The gas must be within the
accuracy stated above to ensure proper calibration.
NOTE: Make sure the monitor is not in STAND BY mode before

proceeding with the following procedure.
Procedure PREPARATION
1. Insert a water trap (CAT 938F-NC) and sample line (CAT 625)
on the 8100E1 monitor. Connect the other end of the sample
line to PORT 2 on the Breath Rate Simulator (CAT 1466).
2. Turn the 8100E1 monitor on and allow to run for 30 minutes.
3. Using the rotary knob, highlight PARAMS. Press the knob to
enter the Parameters menu. Verify that CO2 is ON. (If the CO2
parameter is off, highlight CO2 using the rotary knob and press
the knob. Turn the knob until YES is displayed and press the
knob to save selection. Press the knob once more to skip the
color choice.)
4. Highlight Unit of Measure underneath CO2, and press the knob
to select. Rotate the knob until PERCENT is highlight; press the
knob to save selection.
5. Highlight EXIT and press the rotary knob to exit the Parameters
menu.
6. Highlight CONFIG and press the rotary knob to enter the
Configuration menu.
7. In the Configuration menu, highlight Enter Service Mode using
the rotary knob. Press the knob to select.
8. Rotate the knob so that YES is highlighted. Press the knob to
enter Service Mode.
9. The Enter Service Mode password box appears. Enter
password PIA418 and press the rotary knob. The Service Mode
window will appear.
CALIBRATION
1. Highlight Enter CO2 Service and press the rotary knob to select.
Rotate the knob to YES and press the knob to enter CO2
Service.
2. Using the regulator (CAT 623) and regulator bleed tube
(CAT 613B), connect the 10% CO2 gas to PORT 1 on the Breath
Rate Simulator. Turn on the Breath Rate Simulator and the 10%
CO2 gas.
3. Highlight CO2 Zero Cal and press the knob to select.
4. Turn the rotary knob until Request CO2 Zero Cal is displayed.
Press the knob to begin a CO2 Zero Cal. Wait for the calibration
to complete (about one (1) minute).
If the EXP CO2 reading is between 10.0 and 10.1% power cycle
the monitor and perform the CO2 Verification earlier in this
appendix. If the EXP CO2 reading is above or below this range
proceed with the remaining steps.
5. Select CO2 Zero Cal with the rotary knob, turn the knob until
Abort CO2 Zero Cal is displayed, and press the knob to abort
the CO2 Zero Cal.
6. Using the rotary knob, highlight CO2 Gain Adjustment and press
to select. Turn the rotary knob clockwise to increase the CO2
reading and counter-clockwise to decrease the it until the CO2
reading is as close to 10.0% as possible.
7. Go back to Step 4 and repeat until the EXP CO2 reading is
between 10.0 and 10.1% at the end of the CO2 Zero Cal.
8. When the EXP CO2 reading is between 10.0 and 10.1%, power
cycle the monitor and perform the CO2 Verification earlier in this
appendix.
Disassembly NOTE: The “CO2 Calibration” and “Gas Flow/C02 Verification” in this
appendix are required after replacing the CO2 absorber or external or
internal modules.
NOTE: Perform appropriate safety tests listed on the “Field Service

Test Matrix” in Section.
NOTE: Before any disassembly of the monitor, the battery must be

disconnected. Follow the procedure below:
Disconnect the Battery 1. Follow all ESD procedures as stated in “Electrostatic Discharge”
in “Section 7 – Disassembly.
2. Remove the two screws (PHMS 4-40 x .500 SEMS;
pn 40995B003) from the battery door.
3. Remove the battery door (pn 45182B001) from the rear monitor
enclosure (pn 45179B001).
4. Disconnect the cables from the battery.
Check/Replace the 1. Follow all ESD procedures as stated in “Electrostatic Discharge”

CO2 Absorber in “Section 7 – Disassembly.”
pn 40496B001) from the external CO2 module (pn 92811A002).
3. Carefully pull the external CO2 module away from the monitor.
4. Once the external module is disconnected from the monitor,
check the condition of the CO2 absorber (pn 40570B004).
5. If the absorber is in good condition, reassemble in reverse order
and perform the “Gas Flow/CO2 Verification” in this appendix.
If the absorber must be replaced, continue with this procedure.

6. Disconnect the absorber.
Disconnect tubing
Absorber
Figure A-3: Disconnect CO2 Absorber

7. Replace CO2 absorber.
Replace the External 1. Follow all ESD procedures as stated in “Electrostatic Discharge”
CO2 Absorber in “Section 7 – Disassembly.”
pn 40496B001) from the external CO2 module (pn 92811A002).
3. Carefully pull the external CO2 module away from the monitor.
4. Replace external CO2 module.
Replace the Internal 1. Follow all ESD procedures as stated in “Electrostatic Discharge”
CO2 Module in “Section 7 – Disassembly.”
2. Remove the printer module (pn 92804A001) or printer cover
(pn 45183B001) from the rear enclosure.
a. Remove the two (2) screws (PHMS 4-40 x .312 SEMS;
pn 40995B001) holding the module or cover to the rear
enclosure.
b. If the monitor has a printer module, label and remove the
ribbon cable from the printer module.
3. Remove the external CO2 module (pn 92811A002) following the
instructions above.
4. Remove the rear enclosure (pn 92810C001).
a. Remove the four (4) nylon screws (PHMS 8-32 x .375
NYLON; pn 42654B002) on the bottom of the enclosure.
NOTE: The plastic insulator bottom (pn 45194B001) will

come off when the screws are removed. Do not lose.
b. Remove the two (2) screws (FHMS 8-32 x .375 PH PL;
pn 40083B002) located under the insulator.
c. Remove the two (2) screws (PHMS 4-40 x .500 SEMS;
pn 40995B003) from the back of the battery door.
d. Remove the two (2) screws (FHMS 6-32 x .375;
pn 40180B002) from the power area.
e. Remove the six (6) screws (PHMS 6-32 x .375 SEMS;
pn 40496B001) holding the rear enclosure to the front
enclosure.
5. Disconnect the ribbon cable at J1 on the internal CO2 module’s
PCB board.
6. Remove the four (4) screws (PHMS 6-32 x .375 SEMS;
pn 40496B001) holding the internal CO2 module
(pn 92811A001) to the chassis.
7. Replace the internal CO2 module.
Troubleshooting SYMPTOM: TRAP ERROR OR CO2 MALFUNCTION
Problem Solution
• Trap is plugged or leaks Replace Trap

• Tubes to the trap manifold are Check manifold connections
loose or pinched
• Bad valve or pump Contact CSI Service Department
Verification Checklist
Functional and Safety Testing Checklist – CO2
This checklist may be copied as needed to record field testing. Add this page
to the “Functional and Safety Testing Checklist” in Section 5 of this manual.
Monitor Serial Number

CO2 Processor Software Rev.
Gas Flow Verification
Pass Fail
Flow Calibration
Occlusion
Exhaust Test
CO2 Test
Certification of CO2 Verification
Technician:
Date:

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nGenuityTM

Cat. No. 1448 Part No. 39166B101

In the event of inadvertent or deliberate publication, Criticare intends to enforce its

All product specifications, as well as information contained in this publication, are

All information contained in this publication is believed to be correct. Criticare

This publication may refer to information and products protected by copyrights or

PROPERTY OF CRITICARE SYSTEMS, INC.

nGenuity™ vital signs monitor, DOX™ Digital Oximetry, ComfortCuff™ NIBP,

Page ii nGenuityTM 8100E Series Service Manual Criticare Systems, Inc.

Description .................................................................................................................... 1-1

Section 2 - Service Windows

Service Mode Window .................................................................................................. 2-1

Section 3 - Theory of Operation

Power Module ...............................................................................................................3-1

Section 4 - Cleaning and Disinfecting

Cleaning and Disinfecting..............................................................................................4-1

Section 5 - Preventative Maintenance

Incoming Inspection ......................................................................................................5-1

Page iv nGenuity™ 8100E Series Service Manual Criticare Systems, Inc.

Section 6 - Service Testing and Calibration

Field Service Testing Safety ......................................................................................... 6-1

Before You Begin.......................................................................................................... 7-1

Criticare Systems, Inc. nGenuityTM 8100E Series Service Manual Page v

Troubleshooting and Repair ..........................................................................................8-3

Section 9 - Drawings and Schematics

Appendix A - CO2 Service

Service Windows.......................................................................................................... A-1

Page vi nGenuity™ 8100E Series Service Manual Criticare Systems, Inc.

In Case of Emergency CRITICARE SYSTEMS, INC. Telephone: (262) 798-8282

Representative in the Criticare Systems Limited

Criticare Systems, Inc. nGenuityTM 8100E Series Service Manual Page ix

Intended Use The 8100E Series monitor is intended to monitor physiological

The user is responsible for the interpretation of the monitored data

The monitor is designed to be used with only one patient at a time.

The nGenuity 8100E Series monitor is also available with ST and

Catalog Number Printer Additional Features

8100E1-ST No CO2, ST Arrhythmia

8100EP Yes Standard

8100EP-ST Yes ST Arrhythmia

8100EP1 Yes CO2

8100EP1-ST Yes CO2, Arrhythmia

Definition Hemoglobin exists in the blood in several forms:

In the monitor, SpO2 (pulse arterial oxygen saturation) is the ratio of

Dyshemoglobins, such as carboxyhemoglobin and methemoglobin,

The plethysmographic pulse wave is not auto-gained. The amplitude

This oximeter is a two-wavelength device, which is calibrated to

SpO2 clinical accuracy validation to CO-oximeter SaO2 readings was

The personal demographics of the study participants for the SpO2

The monitor has a user selectable smart heart rate function. It

The pulse rate accuracy for SpO2 is the root-mean-square (rms)

NOTE: The NIBP based heart rate is not a continuous measurement

The monitor has user selectable automatic lead switching capability

The accuracy of the monitor is not affected by arrhythmia or other

The accuracy of the ECG analog output bandwidth is equal to the

The accuracy of the synchronizing pulse amplitude is equal to 500

When determining respiration from the ECG, the monitor measures

Non-Invasive Blood The monitor uses ComfortCuff technology to determine non-invasive

As cuff pressure continues to increase, the pulse waveform (as

Dynamic Measurement Ranges

Systolic (mmHg) Diastolic (mmHg) MAP (mmHg)

Adult 50-280 30-225 35-245

Pediatric 50-280 30-225 35-245

Neonate 50-135 20-100 30-120

Cuff deflates rapidly